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

Last updated: February 27, 2025
Sponsor: Biosense Webster, Inc.
Overall Status: Completed

Phase

4

Condition

Chest Pain

Arrhythmia

Atrial Fibrillation

Treatment

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

Radiofrequency ablation, antiarrhythmic drugs

ThermoCool Radiofrequency Catheter

Clinical Study ID

NCT00540787
A4
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years of age or older

  • Paroxysmal atrial fibrillation for at least 6 months with at least 2 symptomaticepisodes (patient history) during the previous month

  • Atrial fibrillation (patient history or echocardiogram documented) resistant to atleast one antiarrhythmic drug of Class I or III

  • Documentation of at least one episode of atrial fibrillation on 12-leadechocardiogram or Holter Monitor

Exclusion

Exclusion Criteria:

  • Contraindications to more than 2 antiarrhythmic drugs of different classes, or tooral 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 amechanical cardiac valve)

Study Design

Total Participants: 112
Treatment Group(s): 3
Primary Treatment: Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs
Phase: 4
Study Start date:
August 01, 2003
Estimated Completion Date:
June 01, 2006

Connect with a study center

  • Hôpital Haut Lèvêque

    Pessac, Paris
    France

    Site Not Available

  • Hopital Lariboisiere

    Paris, 75010
    France

    Site Not Available

  • Hopital Cantonal de Geneve

    Geneva, 12111
    Switzerland

    Site Not Available

  • University of Alabama, Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Mid-Ohio Cardiology

    Columbus, Ohio 43214
    United States

    Site Not Available

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