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    Clinical Trial Results:
    Atrial Fibrillation Progression Trial (ATTEST)

    Summary
    EudraCT number
    		 2012-002338-35
    Trial protocol
    		 DE   CZ   AT   SE   ES   IE   GB  
    Global end of trial date
    29 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 May 2020
    First version publication date
    17 May 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ATTEST
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01570361
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Johnson & Johnson Medical N.V., Biosense Webster
    Sponsor organisation address
    3333 Diamond Canyon Road Diamond Bar, Diamond Bar, United States, CA 91765
    Public contact
    Liesbeth Vanderlinden, Johnson & Johnson Medical N.V., Biosense Webster, +32 0 2 746 3446, lvanderl@its.jnj.com
    Scientific contact
    Liesbeth Vanderlinden, Johnson & Johnson Medical N.V., Biosense Webster, +32 0 2 746 3446, lvanderl@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 May 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 May 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main purpose of this study was to determine whether, in subjects with paroxysmal atrial fibrillation (PAF), early radiofrequency (RF) ablation treatment using the THERMOCOOL® Catheter Family in conjunction with the CARTO® 3, CARTO® XP, or CARTO® RMT System delays progression of atrial fibrillation (AF) compared with drug therapy (either rate or rhythm control) using current AF management guidelines.
    Protection of trial subjects
    This study was performed in accordance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use – Good Clinical Practice (ICH-GCP) and ensure the protection of the subjects as per Declaration of Helsinki and local regulations. The safety was monitored by assessing adverse events throughout the study. Also, evaluations were done using 12-lead electrocardiograms (ECGs), Holter monitoring, event recording, transesophageal and transthoracic echocardiograms, and cardioversions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Feb 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 37
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Austria: 5
    Country: Number of subjects enrolled
    Russian Federation: 115
    Country: Number of subjects enrolled
    Norway: 1
    Country: Number of subjects enrolled
    Hungary: 25
    Country: Number of subjects enrolled
    Sweden: 3
    Country: Number of subjects enrolled
    Latvia: 23
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Italy: 12
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 14
    Worldwide total number of subjects
    255
    EEA total number of subjects
    126
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    70
    From 65 to 84 years
    185
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first subject was enrolled on 13-Feb-2012. On 27-Feb-2018, study was terminated early due to enrollment not proceeding in accordance with expectations, independently from the study outcome. The last subject completed the last visit on 29-May-2018.

    Pre-assignment
    Screening details
    		 Before randomization and signing inform consent forms, all subjects were screened according protocol defined inclusion and exclusion criteria. Screening failures were excluded from the study and were not randomized.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Radiofrequency (RF) ablation treatment
    Arm description
    		 Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).
    Arm type
    		 RF ablation treatment

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Antiarrhythmic drug (AAD) therapy
    Arm description
    		 Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Subjects who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Antiarrhythmic drug (AAD) therapy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Buccal tablet, Tablet, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Antiarrhythmic drug (AAD) therapy in accordance with 2006 atrial fibrillation management guidelines.

    Number of subjects in period 1
    		Radiofrequency (RF) ablation treatment Antiarrhythmic drug (AAD) therapy
    Started
    128
    127
    Received Study Treatment
    102
    123
    Cross-over (AAD therapy to RF Ablation)
    0 [1]
    15 [2]
    AAD Therapy only
    0 [3]
    108
    Completed
    46
    52
    Not completed
    82
    75
         Adverse event, serious fatal
    5
    4
         Subject withdrew consent
    14
    9
         Adverse event, non-fatal
    2
    1
         Other
    -
    2
         Sponsor closing the study
    51
    50
         Subject discontinued
    1
    2
         Lost to follow-up
    4
    4
         Subject excluded
    5
    3
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only 15 participants were cross-over from RF Ablation arm to AAD Therapy arm.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only 15 participants were cross-over from RF Ablation arm to AAD Therapy arm.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only 15 participants were cross-over from RF Ablation arm to AAD Therapy arm.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Radiofrequency (RF) ablation treatment
    Reporting group description
    		 Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).

    Reporting group title
    Antiarrhythmic drug (AAD) therapy
    Reporting group description
    		 Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Subjects who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).

    Reporting group values
    		 Radiofrequency (RF) ablation treatment Antiarrhythmic drug (AAD) therapy Total
    Number of subjects
    		 128 127 255
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 35 36 71
        From 65 to 84 years
    		 93 91 184
    Age Continuous
    Units: Year
        arithmetic mean (standard deviation)
    		 67.8 ( 4.83 ) 67.6 ( 4.64 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 74 74 148
        Male
    		 54 53 107

    End points

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    End points reporting groups
    Reporting group title
    Radiofrequency (RF) ablation treatment
    Reporting group description
    		 Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™).

    Reporting group title
    Antiarrhythmic drug (AAD) therapy
    Reporting group description
    		 Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. Subjects who met eligibility criteria were allowed for crossed over to RF ablation treatment (second treatment) followed by AAD therapy (first treatment).

    Primary: Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years

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    End point title
    		 Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years
    End point description
    Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. Here '99999' signifies that due to insufficient number of participants with events, median time and 95% CI could not be estimated using Kaplan-Meier method.
    End point type
    Primary
    End point timeframe
    3 years
    End point values
    		 Radiofrequency (RF) ablation treatment Antiarrhythmic drug (AAD) therapy
    Number of subjects analysed
    128
    127
    Units: Months
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Radiofrequency (RF) ablation treatment v Antiarrhythmic drug (AAD) therapy
    Number of subjects included in analysis
    255
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0009 [1]
    Method
    		 Log Rank one sided
    Confidence interval
    Notes
    [1] - Prior to the final analysis, this study had two interim analyses. Hence the alpha level is 0.0231 for the primary analysis adjusted for the two interim analyses. p-value is one sided.

    Secondary: Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year

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    End point title
    		 Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year
    End point description
    Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. ITT, including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. Here '99999' signifies that due to insufficient number of participants with events, Kaplan Meier (KM) estimated median time and 95% CI could not be estimated.
    End point type
    Secondary
    End point timeframe
    1 year
    End point values
    		 Radiofrequency (RF) ablation treatment Antiarrhythmic drug (AAD) therapy
    Number of subjects analysed
    128
    127
    Units: Months
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Radiofrequency (RF) ablation treatment v Antiarrhythmic drug (AAD) therapy
    Number of subjects included in analysis
    255
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0118 [2]
    Method
    		 Log Rank one sided
    Confidence interval
    Notes
    [2] - The alpha level is 0.025 for this secondary endpoint.

    Secondary: Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years.

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    End point title
    		 Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years.
    End point description
    Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. ITT, including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. Here '99999' signifies that due to insufficient number of participants with events, median time and 95% CI could not be estimated using Kaplan-Meier method.
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Radiofrequency (RF) ablation treatment Antiarrhythmic drug (AAD) therapy
    Number of subjects analysed
    128
    127
    Units: Month
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Radiofrequency (RF) ablation treatment v Antiarrhythmic drug (AAD) therapy
    Number of subjects included in analysis
    255
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0041 [3]
    Method
    		 Log rank one sided
    Confidence interval
    Notes
    [3] - The alpha level is 0.025 for this secondary endpoint.

    Secondary: Percentage of Subjects with Persistent Atrial Fibrillation/Atrial Tachycardia at 1 year

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    End point title
    		 Percentage of Subjects with Persistent Atrial Fibrillation/Atrial Tachycardia at 1 year
    End point description
    Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 1 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
    End point type
    Secondary
    End point timeframe
    1 year
    End point values
    		 Radiofrequency (RF) ablation treatment Antiarrhythmic drug (AAD) therapy
    Number of subjects analysed
    128
    127
    Units: Percentage of subjects
        number (confidence interval 95%)
    1.3 (0.2 to 8.6)
    6.5 (3.2 to 13.2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 2 year

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    End point title
    		 Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 2 year
    End point description
    Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 2 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    		 Radiofrequency (RF) ablation treatment Antiarrhythmic drug (AAD) therapy
    Number of subjects analysed
    128
    127
    Units: Percentage of participants
        number (confidence interval 95%)
    2.4 (0.6 to 9.4)
    12.4 (7.2 to 21.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year

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    End point title
    		 Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year
    End point description
    Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Radiofrequency (RF) ablation treatment Antiarrhythmic drug (AAD) therapy
    Number of subjects analysed
    128
    127
    Units: Percentage of participants
        number (confidence interval 95%)
    2.4 (0.6 to 9.4)
    17.5 (10.7 to 27.8)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations

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    End point title
    		 Percentage of Subjects with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years by Number of Repeat Ablations [4]
    End point description
    Percentage of Participants with Persistent Atrial Fibrillation/Atrial Tachycardia at 3 year by number of repeat ablations were reported. The percentage of participants was calculated using Kaplan Meier (KM) rate estimate. Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours. Intent to treat population (ITT), including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. Endpoint applicable only to subjects randomized into the test group (RF Ablation). Here '99999' signifies that due to insufficient number of participants with events, 95% CI could not be estimated using Kaplan-Meier method.
    End point type
    Secondary
    End point timeframe
    3 years
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for any of the arms of this endpoint.
    End point values
    		 Radiofrequency (RF) ablation treatment
    Number of subjects analysed
    128
    Units: Percentage of subjects
    number (confidence interval 95%)
        Number of ablations = 0 (n=25)
    0.0 (-99999 to 99999)
        Number of ablations = 1 (n=89)
    1.5 (0.2 to 10.4)
        2 or more ablations (n=14)
    7.7 (1.1 to 43.4)
    No statistical analyses for this end point

    Secondary: Number of Repeat Ablations

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    End point title
    		 Number of Repeat Ablations
    End point description
    Number of repeat ablations refers to the total number of ablation procedures (including initial ablation procedure). If the number of repeat ablations =1 then subject only had one ablation procedure (initial ablation procedure in test group as randomized or cross-over procedure in cross-over subjects). If the number of repeat ablations is >= 2, then subject had at least one repeat procedure. ITT population includes all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. Here ‘N (number of subjects analyzed)’ signifies the subjects in the Intent to treat population (ITT) who were randomized to RF ablation or who received any RF ablations as Cross-Over Patients randomized to AAD group.
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Radiofrequency (RF) ablation treatment Antiarrhythmic drug (AAD) therapy
    Number of subjects analysed
    128
    15
    Units: Event of ablation
        arithmetic mean (standard deviation)
    0.9 ( 0.57 )
    1.1 ( 0.26 )
    No statistical analyses for this end point

    Secondary: Number of New Antiarrhythmic Drugs

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    End point title
    		 Number of New Antiarrhythmic Drugs
    End point description
    Number of new antiarrhythmic drugs were administered as per investigator’s discretion and 2006 AF management guidelines. ITT population set including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received.
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Radiofrequency (RF) ablation treatment Antiarrhythmic drug (AAD) therapy
    Number of subjects analysed
    128
    127
    Units: AAD drug
        arithmetic mean (standard deviation)
    0.8 ( 1.05 )
    1.0 ( 1.23 )
    No statistical analyses for this end point

    Secondary: Number of Subjects in Sinus Rhythm at Each Visit Throughout the Follow-up

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    End point title
    		 Number of Subjects in Sinus Rhythm at Each Visit Throughout the Follow-up
    End point description
    Subject in sinus rhythm: no other rhythms documented at specific visit, based on ECG, Holter and event recorder. Percentages are calculated with respect to number of subjects with data available at corresponding visit. ITT population set including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. The number of subjects analyzed at each visit is the number of subjects with available data at the visit. Here 'n' number analyzed signifies number of subjects evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    3 months, 6 months, 1 year, 2 years, 3 years
    End point values
    		 Radiofrequency (RF) ablation treatment Antiarrhythmic drug (AAD) therapy
    Number of subjects analysed
    128
    127
    Units: Subjects
        3 months follow up (n= 69, 80)
    51
    55
        6 months follow up (n= 62, 60)
    49
    42
        1 year follow up (n= 54, 53)
    41
    35
        2 year follow up (n= 44, 44)
    37
    30
        3 year follow up (n= 27, 35)
    20
    23
    No statistical analyses for this end point

    Secondary: Number of Subjects with Recurrent AF/AT at Each Visit Throughout the Follow-up

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    End point title
    		 Number of Subjects with Recurrent AF/AT at Each Visit Throughout the Follow-up
    End point description
    Subjects with recurrent AF/AT: any AF/AT documented between previous visit up to visit analyzed at any TTM, Holter or ECG. Percentages are calculated with respect to number of subjects with data available at corresponding visit. ITT population set including all subjects randomized, where subjects were classified by the group to which they were randomized, regardless of the treatment received. Here 'n' number analyzed signifies number of subjects evaluable for specified categories.
    End point type
    Secondary
    End point timeframe
    3 months, 6 months, 1 year, 2 year and 3 years
    End point values
    		 Radiofrequency (RF) ablation treatment Antiarrhythmic drug (AAD) therapy
    Number of subjects analysed
    128
    127
    Units: Subjects
        3 months follow up (n= 101,114)
    17
    20
        6 months follow up (n= 96, 110)
    17
    45
        1 year follow up (n= 88, 87)
    20
    38
        2 years follow up (n= 72, 73)
    16
    30
        3 years follow up (n= 51, 55)
    10
    17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    3 years follow up
    Adverse event reporting additional description
    Adverse events are summarized using the Safety population, which includes all subjects who had undergone insertion of an ablation catheter, either as RF ablation group or cross-over subjects; subjects who had started an investigator prescribed AAD in the AAD Group and did not initiate ablation therapy.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Radiofrequency (RF) ablation treatment
    Reporting group description
    		 Radiofrequency (RF) ablation treatment for subjects with Paroxysmal Atrial Fibrillation (PAF) using the CARTO® 3 or CARTO® XP System, CARTO RMT, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™)

    Reporting group title
    Antiarrhythmic drug (AAD) therapy only
    Reporting group description
    		 Antiarrhythmic Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with 2006 atrial fibrillation management guidelines. This group includes only those subjects received AAD only.

    Reporting group title
    Antiarrhythmic drug (AAD) therapy - first treatment
    Reporting group description
    		 This group of subjects received Antiarrhythmic drug (AAD) therapy first and received RF ablation treatment later. The AEs are those occurred during the AAD treatment period.

    Reporting group title
    Radiofrequency (RF) ablation - second treatment
    Reporting group description
    		 This group of subjects received Antiarrhythmic drug (AAD) therapy first and received RF ablation treatment later. The AEs are those occurred during the RF treatment period.

    Serious adverse events
    		 Radiofrequency (RF) ablation treatment Antiarrhythmic drug (AAD) therapy only Antiarrhythmic drug (AAD) therapy - first treatment Radiofrequency (RF) ablation - second treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    38 / 102 (37.25%)
    30 / 108 (27.78%)
    7 / 15 (46.67%)
    4 / 15 (26.67%)
         number of deaths (all causes)
    5
    4
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign neoplasm of bladder
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer recurrent
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Arteriovenous fistula
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 1
    Hypertension
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abscess drainage
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac ablation
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hernia repair
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    3 / 102 (2.94%)
    2 / 108 (1.85%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inflammation
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic prolapse
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Major depression
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device lead damage
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Arteriogram coronary
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Acetabulum fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 108 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    8 / 102 (7.84%)
    7 / 108 (6.48%)
    4 / 15 (26.67%)
    3 / 15 (20.00%)
         occurrences causally related to treatment / all
    2 / 13
    0 / 9
    1 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    4 / 102 (3.92%)
    2 / 108 (1.85%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    4 / 102 (3.92%)
    2 / 108 (1.85%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 108 (0.93%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracardiac thrombus
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachyarrhythmia
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    Dizziness postural
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nerve degeneration
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radicular syndrome
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Eyelid oedema
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Chronic gastritis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Faeces discoloured
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic pseudocyst
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Proctalgia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stenosis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 108 (1.85%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Perineal abscess
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Radiofrequency (RF) ablation treatment Antiarrhythmic drug (AAD) therapy only Antiarrhythmic drug (AAD) therapy - first treatment Radiofrequency (RF) ablation - second treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 102 (36.27%)
    43 / 108 (39.81%)
    6 / 15 (40.00%)
    4 / 15 (26.67%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Haemorrhage
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hypertension
         subjects affected / exposed
    1 / 102 (0.98%)
    2 / 108 (1.85%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Hypertensive crisis
         subjects affected / exposed
    1 / 102 (0.98%)
    2 / 108 (1.85%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Hypertensive emergency
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypotension
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    1
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Fatigue
         subjects affected / exposed
    2 / 102 (1.96%)
    2 / 108 (1.85%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Vessel puncture site pain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Reproductive system and breast disorders
    Prostatic disorder
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 102 (0.98%)
    5 / 108 (4.63%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    5
    0
    1
    Bronchospasm
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Body temperature increased
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Electrocardiogram change
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Heart rate irregular
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Prostatic specific antigen increased
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lower limb fracture
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rib fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Upper limb fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vascular pseudoaneurysm
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Congenital, familial and genetic disorders
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 108 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Aortic valve incompetence
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    13 / 102 (12.75%)
    20 / 108 (18.52%)
    2 / 15 (13.33%)
    1 / 15 (6.67%)
         occurrences all number
    14
    22
    2
    2
    Atrial flutter
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Atrial thrombosis
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Bradycardia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac failure
         subjects affected / exposed
    0 / 102 (0.00%)
    3 / 108 (2.78%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac valve disease
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pericardial effusion
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Tachycardia
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Nervous system disorders
    Cerebral ischaemia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Neuralgia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Syncope
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vertigo
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 108 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Constipation
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 108 (0.00%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 108 (0.93%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Large intestine polyp
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    0
    1
    Proctalgia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Endocrine disorders
    Thyroid disorder
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Bursitis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 108 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Conjunctivitis bacterial
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Systemic infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 108 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Hyperlipidaemia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 108 (0.93%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Oct 2012
    The language was broadened to allow all ThermoCool catheters to be used in conjunction with CARTO systems. The definition of the study locations was broadened to include North America. Further clarification of the subject population was added not to include first-line treatment subjects. The definition of paroxysmal atrial fibrillation (AF) was clarified. Clarification was added on the risk analysis for antiarrhythmic drug (AAD) drugs. Exclusion of subjects with persistent AF was added. The study entry criteria were clarified (reversible causes of AF and atrial thrombus detection technique). The definition of “lost to follow-up” was clarified. Clarification that only validated versions of the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire in country-specific languages would be used. Clarification of subject assessments (including the table for Summary of Subject Assessments) and safety follow up for crossover subjects was added, together with the transtelephonic monitoring (TTM) start day and TTM/ transthoracic echocardiography (TTE) timelines. Blood sampling for metabolite determination was removed from the cross-over procedure. Clarified that cardioversion as part of a (re)-ablation procedure did not count as reaching the primary endpoint. Adverse event definitions/classifications were revised to comply with applicable regulations requirements, with information previously held in an appendix moved to the protocol body. The complaint reporting section was revised to comply with applicable regulations requirements. The timelines of the interim analyses were updated. Administrative responsibilities were clarified, including ethics committee (EC) approval of the study documents (protocol, amendments, informed consent form [ICF]), the monitoring procedures, and the description of source documentation. The study period was updated to include 2012.
    09 Apr 2013
    The study entry criteria were revised to enhance enrollment, reducing the required number of AF episodes from 6 to 2. A note correcting the minimum ejection fraction was added (from greater than (>)50 percent (%) to >=50%). Clarification was made regarding the time-interval related statistical deliverables to be reviewed during the interim analysis.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    29 May 2018
    The study was terminated early on 29-May-2018 due to slow enrollment.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    As the study was terminated early without having met primary effectiveness or futility criteria, the study results should be interpreted with caution.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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