Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Atrial fibrillation ablation; Drug: Antiarrhythmic drug

• Registration Number: NCT00863213
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-16
• Study First Posted: 2009-03-17
• Primary Completion: 2011-03
• Study Completion: 2012-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-25
• Last Update Posted: 2013-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atrial Fibrillation Ablation	Atrial fibrillation ablation	-
Drug therapy	Antiarrhythmic drug	-

Primary Outcome Measures

Name	Time	Method
Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion.	1-year follow-up

Secondary Outcome Measures

Name	Time	Method
Freedom from atrial arrhythmias (lasting more than 30 seconds) without antiarrhythmic drugs.	1-year follow-up
Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences.	1-year follow-up
Decrease in atrial fibrillation/atrial flutter related hospital admissions	1-year follow-up
Improve in quality of life measured with standard questionary for Atrial Fibrillation: AF-QoL.	1-year follow-up
Change in need of cardioversions	From 3rd to 12th months
Need of atrio-ventricular node ablation	1-year follow-up
Need of crossover to the other arm of the study (only when primary end point has been reached)	1-year follow-up
Need of a new intervention or ablation during blanking period	Until 3rd month
Detection of asymptomatic episodes by Reveal XT	1-year follow-up
Presence of any complications in the acute phase or during follow-up	1-year follow-up

Trial Locations

Locations (8)

Hospital de Cruces; 🇪🇸 Bilbao, Bizkaia, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital de Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Clinic Universitari; 🇪🇸 Barcelona, Spain

Hospital Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain

Clínica Puerta de Hierro; 🇪🇸 Madrid, Spain