A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation

Phase 4

Completed

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Device: Radiofrequency ablation, antiarrhythmic drugs; Drug: Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs; Device: ThermoCool Radiofrequency Catheter

• Registration Number: NCT00540787
• Lead Sponsor: Biosense Webster, Inc.

Brief Summary

The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08-01
• Primary Completion: 2006-06-01
• Study Completion: 2006-06-01
• Study First Submitted: 2007-10-04
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• 18 years of age or older
• Paroxysmal atrial fibrillation for at least 6 months with at least 2 symptomatic episodes (patient history) during the previous month
• Atrial fibrillation (patient history or echocardiogram documented) resistant to at least one antiarrhythmic drug of Class I or III
• Documentation of at least one episode of atrial fibrillation on 12-lead echocardiogram or Holter Monitor

Exclusion Criteria

• Contraindications to more than 2 antiarrhythmic drugs of different classes, or to oral anticoagulants
• History of any previous ablation for atrial fibrillation
• Intracardiac thrombus
• Atrial fibrillation due to reversible cause
• Pregnancy
• Contraindication to stopping oral anticoagulation (for example as a result of a mechanical cardiac valve)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug Treatment	Radiofrequency ablation, antiarrhythmic drugs	-
Drug Treatment	Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs	-
ThermoCool Radiofrequency Catheter	Radiofrequency ablation, antiarrhythmic drugs	Radiofrequency catheter used.
ThermoCool Radiofrequency Catheter	ThermoCool Radiofrequency Catheter	Radiofrequency catheter used.

Primary Outcome Measures

Name	Time	Method
Recurrence of Atrial Fibrillation	One year	To compare the incidence of recurrence of Atrial Fibrillation in the two groups over a follow-up period of one year.

Secondary Outcome Measures

Name	Time	Method
Efficacy of ablation and drug treatment	One year	Evaluation of: * the functional state of the 2 groups of patients in terms of quality of life; * the efficacy of the subgroup receiving amiodarone as compared to curative ablation; * the incidence of secondary effects of both approaches; * the rate of withdrawal from oral anticoagulation at 1 year after randomization; * the effect of ablation for maintenance of sinus rhythm with previously ineffective drugs in case of failure of ablation strategy (after cross-over to medical treatment); * the assessment of Atrial fibrillation burden in both groups (using patient diaries and Holter Monitors)

Trial Locations

Locations (6)

Hôpital Haut Lèvêque; 🇫🇷 Pessac, Paris, France

Hopital Cantonal de Geneve; 🇨🇭 Geneva, Switzerland

Hopital Lariboisiere; 🇫🇷 Paris, France

University of Alabama, Birmingham; 🇺🇸 Birmingham, Alabama, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Mid-Ohio Cardiology; 🇺🇸 Columbus, Ohio, United States