Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation - Full Text View

Sponsor:	Hospital Clinic of Barcelona
Collaborators:	Medtronic Fundacio Clinic Biosense Webster, Inc.
Information provided by:	Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT00863213

Purpose

The purpose of this study is to compare the effectivity and safety of atrial fibrillation ablation, in comparison to antiarrhythmic drug therapy in patients with refractory, persistent atrial fibrillation.

Condition	Intervention	Phase
Atrial Fibrillation	Procedure: Atrial fibrillation ablation Drug: Antiarrhythmic drug	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Study of Ablation vs antiaRrhythmic Drugs in Persistent Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

Freedom from recurrent atrial fibrillation or atrial flutter, lasting more than 24 hours or requiring cardioversion. [ Time Frame: From 3rd to 12th months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Freedom form atrial fibrillation or atrial flutter (lasting more than 30 seconds) without antiarrhythmic drugs. [ Time Frame: From 3rd to 12th month ] [ Designated as safety issue: No ]
Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences. [ Time Frame: From 3rd to 12th month ] [ Designated as safety issue: No ]
Decrease in atrial fibrillation/atrial flutter related hospital admissions [ Time Frame: From 3rd to 12th month ] [ Designated as safety issue: No ]
Improve in quality of life measured with SF-36 questionnaire [ Time Frame: Baseline, 6th and 12th month. ] [ Designated as safety issue: No ]
Change in need of cardioversions [ Time Frame: From 3rd to 12th months ] [ Designated as safety issue: No ]
Need of atrio-ventricular node ablation [ Time Frame: From 3rd to 12th month ] [ Designated as safety issue: No ]
Need of crossover to the other arm of the study (only when primary end point has been reached) [ Time Frame: From 3rd to 12th month. ] [ Designated as safety issue: No ]
Need of a new intervention or ablation during blanking period [ Time Frame: Until 3rd month ] [ Designated as safety issue: No ]
Detection of asymptomatic episodes by Reveal XT [ Time Frame: From 3rd to 12th month ] [ Designated as safety issue: No ]
Presence of any complications in the acute phase or during follow-up [ Time Frame: Until 12th month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	208
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Atrial Fibrillation Ablation: Experimental	Procedure: Atrial fibrillation ablation Atrial fibrillation ablation with radiofrequency, guided by 3D navigation map. Either 4mm or cooled tip-catheters will be used. It will include, at least, pulmonary veins isolation; all other radiofrequency lines, including roof and mitral isthmus line, and complex fractioned electrograms ablation will be performed according to each Hospital protocol. Radiofrequency lines block will be tested.
Drug therapy: Active Comparator	Drug: Antiarrhythmic drug Usual drug therapy for atrial fibrillation. In patients with structural heart disease, amiodarone is recommended, while flecainide plus diltiazem or beta-blockers are encouraged in patients without structural heart diseases.

Arms

Assigned Interventions

Atrial Fibrillation Ablation: Experimental

Procedure: Atrial fibrillation ablation

Atrial fibrillation ablation with radiofrequency, guided by 3D navigation map. Either 4mm or cooled tip-catheters will be used.

It will include, at least, pulmonary veins isolation; all other radiofrequency lines, including roof and mitral isthmus line, and complex fractioned electrograms ablation will be performed according to each Hospital protocol. Radiofrequency lines block will be tested.

Drug therapy: Active Comparator

Drug: Antiarrhythmic drug

Usual drug therapy for atrial fibrillation. In patients with structural heart disease, amiodarone is recommended, while flecainide plus diltiazem or beta-blockers are encouraged in patients without structural heart diseases.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with persistent atrial fibrillation (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion)

Exclusion Criteria:

Hypo or hyperthyroidism
Persistent atrial fibrillation lasting more than 1 year or non-defined duration
Hypertrophic myocardiopathy
Implantable defibrillation or pacemaker implanted
Moderate or severe mitral valve disease or mitral prosthetic valve
Ejection fraction less than 30%
Left atrial anteroposterior diameter more than 50 mm.
Previous atrial fibrillation ablation
Contraindication to anticoagulation
Left atrium thrombus
Current infective disease or sepsis
Pregnant women
Current unstable angor
Acute myocardial infarction in last 3 months
Atrial fibrillation secondary to ionic disturbance, thyroids disease or secondary to any other reversible or non cardiovascular disease
Reduced expectancy of life (less than 12 months)
Patient participating in another clinical study that investigates a drug or device
Psychologically unstable patient or denies to give informed consent
Any cause that contraindicate ablation procedure or antiarrhythmic drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863213

Contacts

Contact: Lluis Mont, MD

+34932275551

lmont@clinic.ub.es

Locations

Spain
Hospital Clinic Universitari	Recruiting
Barcelona, Spain, 08036
Principal Investigator: Lluís Mont, MD
Hospital de Sant Pau	Recruiting
Barcelona, Spain
Principal Investigator: Xavier Viñolas, MD
Hospital Gregorio Marañon	Recruiting
Madrid, Spain
Principal Investigator: Angel Arenal, MD
Hospital Clínico San Carlos	Recruiting
Madrid, Spain
Principal Investigator: Julián Villacastin, MD
Hospital Ramón y Cajal	Recruiting
Madrid, Spain
Principal Investigator: Antonio Hernandez Madrid, MD
Clínica Puerta de Hierro	Recruiting
Madrid, Spain
Principal Investigator: Ingacio Fernández-Lozano, MD
Hospital 12 de Octubre	Recruiting
Madrid, Spain
Principal Investigator: Fernando Arribas, MD
Spain, Bizkaia
Hospital de Cruces	Recruiting
Bilbao, Bizkaia, Spain
Principal Investigator: Andres Bodegas, MD

Sponsors and Collaborators

Hospital Clinic of Barcelona

Medtronic

Fundacio Clinic

Biosense Webster, Inc.

Investigators

Study Chair:	Lluís Mont, MD	Hospital Clinic de Barcelona
Study Director:	Angel Arenal, MD	Hospital Gregorio Marañon
Study Director:	Julian Villacastin, MD	Hospital Clínico San Carlos

More Information

No publications provided

Responsible Party:	Hospital Clinic de Barcelona ( Lluis Mont )
Study ID Numbers:	SARA-08, EudraCT: 2008-006095-30
Study First Received:	March 16, 2009
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00863213 History of Changes
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Clinic of Barcelona:

Catheter Ablation, Radiofrequency
Atrial fibrillation
Antiarrhythmic Drugs

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents

Anti-Arrhythmia Agents
Atrial Fibrillation
Pharmacologic Actions
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010