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

February 27, 2025 updated by: Biosense Webster, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hopital Lariboisiere
    • Paris
      • Pessac, Paris, France
        • Hopital Haut Leveque
  • Switzerland
      • Geneva, Switzerland, 12111
        • Hopital Cantonal de Geneve
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama, Birmingham
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Mid-Ohio Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Drug Treatment
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.
Active Comparator: ThermoCool Radiofrequency Catheter
Radiofrequency catheter used.
Device: Radiofrequency ablation, antiarrhythmic drugs
Patients receive either treatment.
Device: ThermoCool Radiofrequency Catheter
Patient is ablated once, repeat ablation if paroxysmal atrial fibrillation reoccurs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of Atrial Fibrillation
Time Frame: One year
To compare the incidence of recurrence of Atrial Fibrillation in the two groups over a follow-up period of one year.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of ablation and drug treatment
Time Frame: 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)
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosense Webster, Inc.

Investigators

  • Principal Investigator: Pierre Jais, MD, Hopital Haut Leveque

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2003

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

October 4, 2007

First Submitted That Met QC Criteria

October 5, 2007

First Posted (Estimated)

October 8, 2007

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Paroxysmal Atrial Fibrillation

Clinical Trials on Radiofrequency ablation, antiarrhythmic drugs

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe