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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.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT00540787
First received: October 4, 2007
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Recurrence of Atrial Fibrillation [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540787

Locations
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
France
Hôpital Haut Lèvêque
Pessac, Paris, France
Hopital Lariboisiere
Paris, France, 75010
Switzerland
Hopital Cantonal de Geneve
Geneva, Switzerland, 12111
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
Principal Investigator: Pierre Jais, MD Hôpital Haut Lèvêque
  More Information

No publications provided by Biosense Webster, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT00540787     History of Changes
Other Study ID Numbers: A4
Study First Received: October 4, 2007
Last Updated: February 21, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cifenline
Dofetilide
Amiodarone
Anti-Arrhythmia Agents
Propafenone
Flecainide
Quinidine
Calcium Channel Blockers
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Membrane Transport Modulators
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Muscarinic Antagonists

ClinicalTrials.gov processed this record on June 17, 2013