Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation

Hospital Clinic of Barcelona8 sites in 1 country152 target enrollmentMarch 2009

ConditionsAtrial Fibrillation

InterventionsAtrial fibrillation ablation Antiarrhythmic drug

DrugsAntiarrhythmic drug

Overview

Phase: Phase 4
Intervention: Atrial fibrillation ablation
Conditions: Atrial Fibrillation
Sponsor: Hospital Clinic of Barcelona
Enrollment: 152
Locations: 8
Primary Endpoint: Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

December 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospital Clinic of Barcelona

Responsible Party

Principal Investigator

Josep Lluis Mont Girbau

MD Phd

Hospital Clinic of Barcelona

Eligibility 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

Arms & Interventions

Atrial Fibrillation Ablation

Intervention: Atrial fibrillation ablation

Drug therapy

Intervention: Antiarrhythmic drug

Outcomes

Primary Outcomes

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

Time Frame: 1-year follow-up

Secondary Outcomes

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)