Overview

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

Status:
Completed
Trial end date:
2006-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Biosense Webster, Inc.
Treatments:
Amiodarone
Anti-Arrhythmia Agents
Calcium Channel Blockers
Cifenline
Dofetilide
Flecainide
Propafenone
Quinidine
Sotalol
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)