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

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540787
• Other study ID #: A4
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2007
• Last updated: February 21, 2012
• Start date: August 2003
• Est. completion date: June 2006

Study information

• Verified date: February 2012
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Radiofrequency ablation, antiarrhythmic drugs
Patients receive either treatment.

Drug:
• Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs
Amiodarone will be taken at 600 mg per day for 21 days (as a loading dose) followed by 1.4g per week or 200mg per day. The daily dose may be increased to 300mg or 2.1g per week.

Device:
• ThermoCool Radiofrequency Catheter
Patient is ablated once, repeat ablation if paroxysmal atrial fibrillation reoccurs.

Locations

Country	Name	City	State
France	Hopital Lariboisiere	Paris
France	Hôpital Haut Lèvêque	Pessac	Paris
Switzerland	Hopital Cantonal de Geneve	Geneva
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Mid-Ohio Cardiology	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

United States,  France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of Atrial Fibrillation	To compare the incidence of recurrence of Atrial Fibrillation in the two groups over a follow-up period of one year.	One year	No
Secondary	Efficacy of ablation and drug treatment	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)	One year	No