A Randomized Comparison of the Efficacy of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation for the Maintenance of Sinus Rhythm In Patients With Paroxysmal Atrial Fibrillation

Biosense Webster, Inc.6 sites in 3 countries112 target enrollmentAugust 1, 2003

ConditionsParoxysmal Atrial Fibrillation

InterventionsRadiofrequency ablation, antiarrhythmic drugs Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs ThermoCool Radiofrequency Catheter

DrugsAmiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs

Overview

Phase: Phase 4
Intervention: Radiofrequency ablation, antiarrhythmic drugs
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Biosense Webster, Inc.
Enrollment: 112
Locations: 6
Primary Endpoint: Recurrence of Atrial Fibrillation
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2003

End Date

June 1, 2006

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biosense Webster, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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)

Arms & Interventions

Drug Treatment

Intervention: Radiofrequency ablation, antiarrhythmic drugs

Drug Treatment

Intervention: Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs