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Completed

NCT Number: NCT00540787

A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation 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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Haut Lèvêque, Pessac, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Radiofrequency ablation, antiarrhythmic drugs

Device

Patients receive either treatment.

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

Drug

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.

ThermoCool Radiofrequency Catheter

Device

Patient is ablated once, repeat ablation if paroxysmal atrial fibrillation reoccurs.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Biosense Webster, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Oct 8, 2007
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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