The purpose of this study is to determine the long-term efficacy of radiofrequency catheter ablation in patients with chronic atrial fibrillation...
Date First Received: January 3, 2006
Last Updated: January 3, 2006
Verified by: University of Michigan, Section of Electrophysiology (Arrhythmia Research), January 2006
Clinical Trial Phase: N/A | Start Date: November 2002
Overall Status: Completed
Estimated Enrollment: 140
Brief Summary
Official Title: “Randomized Comparison of Radiofrequency Catheter Ablation Vs. Antiarrhythmic Therapy With Amiodarone for Maintaining Sinus Rhythm in Patients With Chronic Atrial Fibrillation”
Condition Keyword(s):
The purpose of this study is to determine the long-term efficacy of radiofrequency catheter ablation in patients with chronic atrial fibrillation.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Procedure: Radiofrequency catheter ablation
- Drug: Amiodarone and cardioversion
Outcome Measures for this Clinical Trial
Primary Measures
- Freedom from atrial fibrillation and atrial flutter in the absence of antiarrhythmic drug therapy at 1 year.
Secondary Measures
- incidence of complications
- changes in left atrial diameter
- changes in left ventricular ejection fraction
- changes in symptom severity
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Chronic atrial fibrillation
Exclusion Criteria:
- Left atrial diameter >55 mm
- Left ventricular ejection fraction <0.30
- Contraindication to amiodarone therapy or anticoagulation with warfarin
- Presence of a mechanical prosthetic valve
- History of a cerebrovascular accident
- Presence of left atrial thrombus on TEE
- Prior attempt at catheter or surgical ablation for atrial fibrillation
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Michigan, Section of Electrophysiology (Arrhythmia Research)
Overall Clinical Trial Officials and Contacts
Hakan Oral, MD Principal Investigator University of Michigan
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00272636
Study ID Number: 2002-0480
ClinicalTrials.gov Identifier: NCT00272636
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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