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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2006

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Drug Treatment
  • Active Comparator: ThermoCool Radiofrequency Catheter
    • Radiofrequency catheter used.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Biosense Webster, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pierre Jais, MD, Principal Investigator, Hôpital Haut Lèvêque

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