Clinical Trials Register

Summary
EudraCT Number:	2012-002338-35
Sponsor's Protocol Code Number:	144
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-05-16
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

Spain - AEMPS

A.2

EudraCT number

2012-002338-35

A.3

Full title of the trial

ATrial FibrillaTion ProgrESsion Trial (ATTEST Trial)

Ensayo sobre la progresión de la fibrilación auricular (estudio ATTEST)

A.3.1

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

Atrial Fibrillation Progression Trial

Ensayo sobre la progresión de la fibrilación auricular (estudio ATTEST)

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	0032478971374
B.5.5	Fax number	00322746 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.2.5	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	Not mentioned (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Digoxina
D.3.9.3	Other descriptive name	Digoxina
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de propafenona
D.3.9.3	Other descriptive name	hidrocloruro de propafenona
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de propafenona
D.3.9.3	Other descriptive name	hidrocloruro de propafenona
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	flecainida acetato
D.3.9.3	Other descriptive name	flecainida acetato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Amiodarona clorhidrato
D.3.9.3	Other descriptive name	Amiodarona clorhidrato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	dronedarona
D.3.9.3	Other descriptive name	dronedarona
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	400
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	propranolol
D.3.9.3	Other descriptive name	propranolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	propranolol
D.3.9.3	Other descriptive name	propranolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	sotalol (DCI) clorhidrato
D.3.9.3	Other descriptive name	sotalol (DCI) clorhidrato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	sotalol (DCI) clorhidrato
D.3.9.3	Other descriptive name	sotalol (DCI) clorhidrato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	160
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	metoprolol (D.O.E.) tartrato,
D.3.9.3	Other descriptive name	metoprolol (D.O.E.) tartrato,
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	atenolol
D.3.9.3	Other descriptive name	atenolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	atenolol
D.3.9.3	Other descriptive name	atenolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	fumarato de bisoprolol
D.3.9.3	Other descriptive name	fumarato de bisoprolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	fumarato de bisoprolol
D.3.9.3	Other descriptive name	fumarato de bisoprolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	fumarato de bisoprolol
D.3.9.3	Other descriptive name	fumarato de bisoprolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SRRR-nebivolol
D.3.9.3	Other descriptive name	SRRR-nebivolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RSSS-nebivolol
D.3.9.3	Other descriptive name	RSSS-nebivolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	carvedilol (DOE)
D.3.9.3	Other descriptive name	carvedilol (DOE)
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6.25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	carvedilol (DOE)
D.3.9.3	Other descriptive name	carvedilol (DOE)
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de verapamilo
D.3.9.3	Other descriptive name	hidrocloruro de verapamilo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de verapamilo
D.3.9.3	Other descriptive name	hidrocloruro de verapamilo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	120
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de verapamilo
D.3.9.3	Other descriptive name	hidrocloruro de verapamilo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	180
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de verapamilo
D.3.9.3	Other descriptive name	hidrocloruro de verapamilo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	240
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diltiazem (DCI) clorhidrato
D.3.9.3	Other descriptive name	Diltiazem (DCI) clorhidrato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
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.2.5	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	Not mentioned (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Digoxina
D.3.9.3	Other descriptive name	Digoxina
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de propafenona
D.3.9.3	Other descriptive name	hidrocloruro de propafenona
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	125
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de propafenona
D.3.9.3	Other descriptive name	hidrocloruro de propafenona
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	flecainida acetato
D.3.9.3	Other descriptive name	flecainida acetato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Amiodarona clorhidrato
D.3.9.3	Other descriptive name	Amiodarona clorhidrato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	dronedarona
D.3.9.3	Other descriptive name	dronedarona
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	400
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	propranolol
D.3.9.3	Other descriptive name	propranolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	propranolol
D.3.9.3	Other descriptive name	propranolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	sotalol (DCI) clorhidrato
D.3.9.3	Other descriptive name	sotalol (DCI) clorhidrato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	sotalol (DCI) clorhidrato
D.3.9.3	Other descriptive name	sotalol (DCI) clorhidrato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	160
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	metoprolol (D.O.E.) tartrato,
D.3.9.3	Other descriptive name	metoprolol (D.O.E.) tartrato,
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	atenolol
D.3.9.3	Other descriptive name	atenolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	atenolol
D.3.9.3	Other descriptive name	atenolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	fumarato de bisoprolol
D.3.9.3	Other descriptive name	fumarato de bisoprolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	fumarato de bisoprolol
D.3.9.3	Other descriptive name	fumarato de bisoprolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	fumarato de bisoprolol
D.3.9.3	Other descriptive name	fumarato de bisoprolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SRRR-nebivolol
D.3.9.3	Other descriptive name	SRRR-nebivolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RSSS-nebivolol
D.3.9.3	Other descriptive name	RSSS-nebivolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	carvedilol (DOE)
D.3.9.3	Other descriptive name	carvedilol (DOE)
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6.25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	carvedilol (DOE)
D.3.9.3	Other descriptive name	carvedilol (DOE)
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de verapamilo
D.3.9.3	Other descriptive name	hidrocloruro de verapamilo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de verapamilo
D.3.9.3	Other descriptive name	hidrocloruro de verapamilo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	120
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de verapamilo
D.3.9.3	Other descriptive name	hidrocloruro de verapamilo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	180
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de verapamilo
D.3.9.3	Other descriptive name	hidrocloruro de verapamilo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	240
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diltiazem (DCI) clorhidrato
D.3.9.3	Other descriptive name	Diltiazem (DCI) clorhidrato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
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.2.5	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	Not mentioned (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Digoxina
D.3.9.3	Other descriptive name	Digoxina
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de propafenona
D.3.9.3	Other descriptive name	hidrocloruro de propafenona
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	125
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de propafenona
D.3.9.3	Other descriptive name	hidrocloruro de propafenona
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	flecainida acetato
D.3.9.3	Other descriptive name	flecainida acetato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Amiodarona clorhidrato
D.3.9.3	Other descriptive name	Amiodarona clorhidrato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	dronedarona
D.3.9.3	Other descriptive name	dronedarona
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	400
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	propranolol
D.3.9.3	Other descriptive name	propranolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	propranolol
D.3.9.3	Other descriptive name	propranolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	sotalol (DCI) clorhidrato
D.3.9.3	Other descriptive name	sotalol (DCI) clorhidrato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	sotalol (DCI) clorhidrato
D.3.9.3	Other descriptive name	sotalol (DCI) clorhidrato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	160
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	metoprolol (D.O.E.) tartrato,
D.3.9.3	Other descriptive name	metoprolol (D.O.E.) tartrato,
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	atenolol
D.3.9.3	Other descriptive name	atenolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	atenolol
D.3.9.3	Other descriptive name	atenolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	fumarato de bisoprolol
D.3.9.3	Other descriptive name	fumarato de bisoprolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	fumarato de bisoprolol
D.3.9.3	Other descriptive name	fumarato de bisoprolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	fumarato de bisoprolol
D.3.9.3	Other descriptive name	fumarato de bisoprolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SRRR-nebivolol
D.3.9.3	Other descriptive name	SRRR-nebivolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RSSS-nebivolol
D.3.9.3	Other descriptive name	RSSS-nebivolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	carvedilol (DOE)
D.3.9.3	Other descriptive name	carvedilol (DOE)
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6.25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	carvedilol (DOE)
D.3.9.3	Other descriptive name	carvedilol (DOE)
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de verapamilo
D.3.9.3	Other descriptive name	hidrocloruro de verapamilo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de verapamilo
D.3.9.3	Other descriptive name	hidrocloruro de verapamilo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	120
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de verapamilo
D.3.9.3	Other descriptive name	hidrocloruro de verapamilo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	180
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de verapamilo
D.3.9.3	Other descriptive name	hidrocloruro de verapamilo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	240
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diltiazem (DCI) clorhidrato
D.3.9.3	Other descriptive name	Diltiazem (DCI) clorhidrato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
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.2.5	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	Not mentioned (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Digoxina
D.3.9.3	Other descriptive name	Digoxina
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de propafenona
D.3.9.3	Other descriptive name	hidrocloruro de propafenona
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	125
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de propafenona
D.3.9.3	Other descriptive name	hidrocloruro de propafenona
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	flecainida acetato
D.3.9.3	Other descriptive name	flecainida acetato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Amiodarona clorhidrato
D.3.9.3	Other descriptive name	Amiodarona clorhidrato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	dronedarona
D.3.9.3	Other descriptive name	dronedarona
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	400
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	propranolol
D.3.9.3	Other descriptive name	propranolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	propranolol
D.3.9.3	Other descriptive name	propranolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	sotalol (DCI) clorhidrato
D.3.9.3	Other descriptive name	sotalol (DCI) clorhidrato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	sotalol (DCI) clorhidrato
D.3.9.3	Other descriptive name	sotalol (DCI) clorhidrato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	160
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	metoprolol (D.O.E.) tartrato,
D.3.9.3	Other descriptive name	metoprolol (D.O.E.) tartrato,
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	atenolol
D.3.9.3	Other descriptive name	atenolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	atenolol
D.3.9.3	Other descriptive name	atenolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	fumarato de bisoprolol
D.3.9.3	Other descriptive name	fumarato de bisoprolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	fumarato de bisoprolol
D.3.9.3	Other descriptive name	fumarato de bisoprolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	fumarato de bisoprolol
D.3.9.3	Other descriptive name	fumarato de bisoprolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SRRR-nebivolol
D.3.9.3	Other descriptive name	SRRR-nebivolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RSSS-nebivolol
D.3.9.3	Other descriptive name	RSSS-nebivolol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	carvedilol (DOE)
D.3.9.3	Other descriptive name	carvedilol (DOE)
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6.25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	carvedilol (DOE)
D.3.9.3	Other descriptive name	carvedilol (DOE)
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de verapamilo
D.3.9.3	Other descriptive name	hidrocloruro de verapamilo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de verapamilo
D.3.9.3	Other descriptive name	hidrocloruro de verapamilo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	120
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de verapamilo
D.3.9.3	Other descriptive name	hidrocloruro de verapamilo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	180
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	hidrocloruro de verapamilo
D.3.9.3	Other descriptive name	hidrocloruro de verapamilo
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	240
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diltiazem (DCI) clorhidrato
D.3.9.3	Other descriptive name	Diltiazem (DCI) clorhidrato
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
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

Fibrilación auricular

E.1.1.1

Medical condition in easily understood language

Abnormal heart rhythm

Ritmo cardiaco anormal.

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 RF ablation treatment, using the CARTO® 3 or CARTO ® XP System, and THERMOCOOL ® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH) in subjects with Paroxysmal AF (PAF), delays progression of AF compared with drug therapy (either rate or rhythm control) using current AF management guidelines.

El objetivo de este estudio consiste en determinar si, en sujetos con FAP, el tratamiento precoz con ARF, utilizando la familia de catéteres THERMOCOOL® junto con el sistema CARTO® 3, CARTO® XP o CARTO® RMT, retrasa la progresión de la FA en comparación con
la farmacoterapia (control de la frecuencia o el ritmo) con arreglo a las directrices actuales sobre el tratamiento de la FA1-4.

E.2.2

Secondary objectives of the trial

Not applicable

No aplica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients with recurrent AF for 2 years, with > or = to 6 episodes over the last 6 months;
- HATCH Score of at least > or = to 1 and < or = to 4.
- Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug).
- Age 60 years or older.
- LA diameter < or = 55mm by TTE.
- LV ejection fraction > or = to 50% when in sinus rhythm or LV ejection fraction > or = to 35% when in AF.
- Signed Patient Informed Consent Form.
- Able and willing to comply with protocol requirements, including all baseline and followup testing

1. Paciente con FAP recurrente durante al menos 2 años, con mayor o igual que 6 episodios en los últimos 6 meses.
2. Puntuación HATCH mayor o igual que 1 y menor o igual que 4c.
3. Paciente apto para recibir ablación con catéter y antiarrítmicos o fármacos para controlar la frecuencia, tras haber fracasado al menos uno pero no más de dos fármacos prescritos para la FA (antiarrítmicos o fármacos para controlar la frecuencia).
4. Edad igual o superior a 60 años.
5. Diámetro de la AI menor o igual que 55 mm mediante ecocardiograma transtorácico (ETT).
6.- Firma del Consentimiento Informado
7.- El pacientees capaz y está dispuesto a cumplir los requisitos del
protocolo, incluidas todas las pruebas basales y de seguimiento

E.4

Principal exclusion criteria

- Patients awaiting cardiac transplantation or other cardiac surgery.
- Acute illness (ongoing) or active systemic infection or sepsis.
- Reversible causes of AF, including thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma.
- Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months.
- Heart failure decompensation.
- Previous stroke.
- Pulmonary embolism or recent atrial embolism/thrombosis.
- Hypertrophic obstructive cardiomyopathy.
- Class IV angina or Class IV CHF (including past or planned heart transplantation).
- Mandated anti-arrhythmic drug therapy for disease conditions other than AF.
- Heritable arrhythmias or increased risk for torsade de pointes with class I or III Drugs.
- Prior LA catheter ablation with the intention of treating AF; prior surgical interventions for AF such as the MAZE procedure.
- Prior AV nodal ablation.
- Patients presenting contra-indications for the study catheter(s), as indicated in the respective Instructions For Use.
- Contraindication to warfarin, other anticoagulation therapy, or all anti-platelet medications.
- Medical conditions limiting expected survival to < 3 years.
- Concurrent participation in any other clinical study.
- Prior history of non-adherence to prescribed drug regimens.
- Previous cardioversion needed> 48 hours after the onset of AF / AT.
-Women of childbearing potential who are pregnant, breast-feeding or plan to become pregnant during the course of the trial.

- Paciente a la espera de un trasplante cardíaco o de otra intervención de cirugía cardíaca.
- Pacientes a la espera de un transplante de corazón u otro tipo de operación cardíaca.
- Enfermedad aguda (en curso) o infección sistémica activa o sepsis
- Causas reversibles de FA, por ejemplo, entre otras, trastornos tiroideos, intoxicación etílica aguda, intervenciones de cirugía mayor o traumatismos recientes.
- Episodios cardíacos recientes, como IM, ICP o intervención de cirugía valvular o derivación en los 3 meses anteriores.
- Descompensación de una insuficiencia cardíaca.
- Diagnóstico previo de FA/TA
- Embolia pulmonar o embolia/trombosis auricular reciente.
- Miocardiopatía hipertrófica obstructiva.
- Angina de pecho en clase IV o ICC en clase IV (incluido un trasplante de corazón pasado o previsto).
- Necesidad de farmacoterapia antiarrítmica por enfermedades distintas de la FA.
- Arritmias hereditarias o riesgo elevado de taquicardia helicoidal con el uso de antiarrítmicos de clase I o III.
- Ablación con catéter previa en la AI con intención de tratar la FA; intervenciones quirúrgicas previas para tratar la FA, como el procedimiento MAZE.
- Ablación del nódulo AV previa.
- Paciente con contraindicaciones para recibir los catéteres del estudio, según se indica en las respectivas instrucciones de empleo.
- Contraindicación del uso de warfarina, otro tratamiento anticoagulante o todos los antiagregantes plaquetarios
- Enfermedades que limiten la supervivencia prevista a < 3 años.
- Participación simultánea en cualquier otro estudio clínico.
- Antecedentes de incumplimiento de regímenes farmacológicos prescritos
- Cardioversión anterior necesaria >48 horas después de la aparición de la FA/TA.
- Mujeres en edad fértil que están embarazadas, en periodo de lactancia o que planean quedarse embarazadas durante el curso del ensayo.

E.5 End points

E.5.1

Primary end point(s)

Time to persistent AF/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.

Tiempo hasta la FA/taquicardia auricular (TA) persistente (con exclusión
del flúter auricular dependiente del istmo) a los 3 años. La FA/TA
persistente está definida como una FA/TA que dura más de 7 días
consecutivos o que necesita ser eliminada mediante cardioversión después
de 48 horas.

E.5.1.1

Timepoint(s) of evaluation of this end point

3 years

3 años

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 followup.
- Rhythm (% subjects in SR, % subjects with recurrent AF) throughout 3 years follow-up.
- Subjects 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 subjects 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.

Eficacia:
- Tasa y tiempo hasta la aparición de FA/TA persistente al cabo de 1 y 2 años, tasa de FA/TA persistente según el número de ablaciones al cabo de 3 años.
- Número de ablaciones repetidas y nuevos FAA por sujeto durante el seguimiento de 3 años.
- Ritmo (% de sujetos en ritmo sinusal [RS], % de sujetos con FA recurrente) durante el seguimiento de 3 años.
- Las enfermedades preexistentes del sujeto o que sean de nueva aparición o hayan empeorado y que podrían asociarse a progresión de la FA se recopilarán en el momento basal y en cada visita de seguimiento durante todo el período del estudio de 3 años; entre los parámetros figurarán la edad y el sexo del sujeto y las siguientes evaluaciones del estado de salud ajeno a la FA: tamaño de la AI, puntuación HATCH, presión arterial, clasificación funcional de las cardiopatías de la NYHA, diabetes, lipidograma, función renal y demencia.
Seguridad:
- Complicaciones relacionadas con el catéter (ablación) y reacciones adversas a medicamentos (FAA).
Variables de economía sanitaria :
- Utilización de recursos sanitarios (número y duración de las hospitalizaciones y visitas no programadas relacionadas con el aparato cardiovascular).
- Calidad de vida (CdV) al cabo de 3 y 6 meses y de 1, 2 y 3 años según los cuestionarios EQ-5D y AFEQT y su variación con respecto al momento basal.

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.

Los criterios de valoración secundarios se evaluarán a los 3 meses, 6 meses, 1 año, 2 años y 3 años como viene descrito anteriormente.

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

Comparación de dos tratamientos estándares recomendados por las directrices internacionales para el tratamiento de la Fibrilación Auricular

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

China

Russian Federation

Switzerland

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

LPLV

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

280

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

270

F.4.2.2

In the whole clinical trial

330

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Patients will continue to receive their routine treatment management plan as deemed necessary by their treating physician as per Standard of Care.

Los pacientes continuaran recibiendo su tratamiento habitual si su médico considerará que debe ser tratado según la práctica clínica habitual

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-09-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-07-31

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-05-29

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