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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
112
Patients receive either treatment.
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.
Patient is ablated once, repeat ablation if paroxysmal atrial fibrillation reoccurs.
University of Alabama, Birmingham
Birmingham, Alabama, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mid-Ohio Cardiology
Columbus, Ohio, United States
Hôpital Haut Lèvêque
Pessac, Paris, France
Recurrence of Atrial Fibrillation
To compare the incidence of recurrence of Atrial Fibrillation in the two groups over a follow-up period of one year.
Time frame: One year
Efficacy of ablation and drug treatment
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)
Time frame: One year
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Hopital Lariboisiere
Paris, France
Hopital Cantonal de Geneve
Geneva, Switzerland