A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation
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
Lead SponsorBiosense Webster, Inc.
StatusCompleted No Results Posted
Indication/ConditionParoxysmal Atrial Fibrillation
Intervention/Treatmentflecainide quinidine dofetilide cifenline succinate propafenone sotalol amiodarone ...
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.
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.
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)