Clinical Trials Register

Summary
EudraCT Number:	2012-002338-35
Sponsor's Protocol Code Number:	144
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2013-07-01
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2012-002338-35

A.3

Full title of the trial

ATrial FibrillaTion ProgrESsion Trial (ATTEST Trial)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Atrial Fibrillation Progression Trial

A.3.2

Name or abbreviated title of the trial where available

ATTEST

A.4.1

Sponsor's protocol code number

144

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01570361

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Biosense Webster, Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Biosense Webster, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Biosense Webster, Inc
B.5.2	Functional name of contact point	Clinical Study Information
B.5.3	Address:
B.5.3.1	Street Address	Leonardo Da Vincilaan 15
B.5.3.2	Town/ city	Diegem
B.5.3.3	Post code	1831
B.5.3.4	Country	Belgium
B.5.4	Telephone number	0032 478 971374
B.5.5	Fax number	0032 2 746 3403
B.5.6	E-mail	attest@its.jnj.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Atrial Fibrillation

E.1.1.1

Medical condition in easily understood language

Abnormal heart rhythm

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	PT
E.1.2	Classification code	10003658
E.1.2	Term	Atrial fibrillation
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The objective of this study is to determine whether early Radiofrequency ablation treatment, using the CARTO® 3 or CARTO ® XP System, and THERMOCOOL ® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with Paroxysmal Atrial Fibrillation (PAF), delays progression of AF compared with drug therapy (either rate or rhythm control) using current AF management guidelines.

E.2.2

Secondary objectives of the trial

There are no secondary objectives.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Patients with recurrent paroxysmal AF for at least 2 years, with ≥ 2 episodes over the last 6 months; 2.HATCH Score of at least ≥1 and ≤ 4 3.Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed at least 1 but no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug). 4.Age 60 years or older. 5.Left Atrium diameter ≤ 55mm by Trans Thoracic Echocardiographie. 6.Left Ventricule ejection fraction ≥ 50% when in sinus rhythm or LV ejection fraction ≥ 35% when in AF. 7.Patient signed the Informed Consent Form and is able and willing to comply with protocol requirements, including all baseline and follow- up testing.

E.4

Principal exclusion criteria

1.Patients awaiting cardiac transplantation or other cardiac surgery. 2.Acute illness (ongoing) or active systemic infection or sepsis which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant of the study. 3.Reversible causes of AF, e.g. but not limited to thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma,… 4.Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months. 5.Heart failure decompensation. 6.Previously diagnosed with persistent/permanent AF/AT 7.Previously required cardioversion >48 hours after onset of AF/AT 8.Subject having previous TIA or stroke (cerebrovascular accident) one year prior to patient enrolment and/or no sufficient recovery. 9.Pulmonary embolism or recent atrial embolism/thrombosis. 10.Hypertrophic obstructive cardiomyopathy. 11.Class IV angina or Class IV CHF (including past or planned heart transplantation). 12.Mandated anti-arrhythmic drug therapy for disease conditions other than AF. 13.Heritable arrhythmias or increased risk for torsade de pointes with class I or III Drugs. 14.Prior LA catheter ablation with the intention of treating AF; prior surgical interventions for AF such as the MAZE procedure. 15.Prior AV nodal ablation. 16.Patients presenting contra-indications for the study catheter(s), as indicated in the respective Instructions For Use. 17.Contraindication to warfarin, other anticoagulation therapy, or all anti-platelet medications. 18.Medical conditions limiting expected survival to < 3 years. 19.Concurrent participation in any other clinical study. 20.Prior history of non-adherence to prescribed drug regimens. 21.Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the trial

E.5 End points

E.5.1

Primary end point(s)

Time to persistent atrial fibrillation (AF) / atrial tachycardia (AT) (excluding isthmus-dependent atrial flutter) at 3 years. Persistent AF/AT is defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.

E.5.1.1

Timepoint(s) of evaluation of this end point

3 years

E.5.2

Secondary end point(s)

Effectiveness:• Rate and time to persistent AF/AT at 1 year and 2 years, rate of persistent AF/AT by number of ablations at 3 years. • Number of repeat ablations and new AAD drugs per subject throughout 3 years follow up. • Rhythm (% subjects in SR, % subjects with recurrent AF) throughout 3 years follow-up. • Subject’s pre-existing or new onset/worsened condition(s), that may be associated with AF progression, will be collected at baseline and at each follow up visit throughout the 3-year study period; parameters include subject’s age and gender and the following assessments of non-AF health status: LA size; HATCH Score; blood pressure; NYHA Functional of heart disease; diabetes; lipid profile; renal function and, dementia. Safety: • Catheter-related complications (ablation); adverse drug reactions (AAD). Health Economics (HE) Outcomes: • Health care utilization (number and length of hospitalizations and unscheduled cardiovascular-related visits). • Quality of Life (QoL) at 3 months, 6 months, 1 year,2 years and 3 years by EQ-5D and AFEQT Questionnaire and change from baseline.

E.5.2.1

Timepoint(s) of evaluation of this end point

secondary end points are evaluated at 3 months, 6 months, 1 year, 2 years and 3 years as described above

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Comparison of two standard of care treatment approach that is recommended by the international Atrial Fibrillation management guidelines

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Radiofrequency Catheter Ablation treatment, CE marked devices used in the approved indications

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

China

Czech Republic

Hungary

Ireland

Italy

Latvia

Norway

Poland

Portugal

Russian Federation

Slovenia

Spain

Sweden

Switzerland

United Kingdom

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1