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Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation

Information source: Hospital Clinic of Barcelona
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation

Intervention: Atrial fibrillation ablation (Procedure); Antiarrhythmic drug (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hospital Clinic of Barcelona

Official(s) and/or principal investigator(s):
Lluís Mont, MD, Study Chair, Affiliation: Hospital Clinic de Barcelona
Angel Arenal, MD, Study Director, Affiliation: Hospital Gregorio Marañon
Julian Villacastin, MD, Study Director, Affiliation: Hospital Clínico San Carlos
Josep Brugada, prof Md. PHD, Study Director, Affiliation: Hospital Clínic de Barcelona


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.

Clinical Details

Official title: Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion.

Secondary outcome:

Freedom from atrial arrhythmias (lasting more than 30 seconds) without antiarrhythmic drugs.

Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences.

Decrease in atrial fibrillation/atrial flutter related hospital admissions

Improve in quality of life measured with standard questionary for Atrial Fibrillation: AF-QoL.

Change in need of cardioversions

Need of atrio-ventricular node ablation

Need of crossover to the other arm of the study (only when primary end point has been reached)

Need of a new intervention or ablation during blanking period

Detection of asymptomatic episodes by Reveal XT

Presence of any complications in the acute phase or during follow-up


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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

Locations and Contacts

Hospital Clinic Universitari, Barcelona 08036, Spain

Hospital de Sant Pau, Barcelona, Spain

Clínica Puerta de Hierro, Madrid, Spain

Hospital 12 de Octubre, Madrid, Spain

Hospital Clínico San Carlos, Madrid, Spain

Hospital Gregorio Marañon, Madrid, Spain

Hospital Ramón y Cajal, Madrid, Spain

Hospital de Cruces, Bilbao, Bizkaia, Spain

Additional Information

Starting date: March 2009
Last updated: April 25, 2013

Page last updated: August 23, 2015

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