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

This study has been completed.
Information provided by (Responsible Party):
Biosense Webster, Inc. Identifier:
First received: October 4, 2007
Last updated: February 21, 2012
Last verified: February 2012
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.

Condition Intervention Phase
Paroxysmal Atrial Fibrillation
Device: Radiofrequency ablation, antiarrhythmic drugs
Drug: Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs
Device: ThermoCool Radiofrequency Catheter
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:

Further study details as provided by Biosense Webster, Inc.:

Primary Outcome 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 Outcome 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)

Enrollment: 112
Study Start Date: August 2003
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00540787

United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Ohio
Mid-Ohio Cardiology
Columbus, Ohio, United States, 43214
Hôpital Haut Lèvêque
Pessac, Paris, France
Hopital Lariboisiere
Paris, France, 75010
Hopital Cantonal de Geneve
Geneva, Switzerland, 12111
Sponsors and Collaborators
Biosense Webster, Inc.
Principal Investigator: Pierre Jais, MD Hôpital Haut Lèvêque
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Biosense Webster, Inc. Identifier: NCT00540787     History of Changes
Other Study ID Numbers: A4
Study First Received: October 4, 2007
Last Updated: February 21, 2012

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Calcium Channel Blockers
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers processed this record on May 25, 2017