Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation

Condition(s) targeted: Atrial Fibrillation

Intervention: Radiofrequency catheter ablation (Procedure); Amiodarone and cardioversion (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Michigan, Section of Electrophysiology (Arrhythmia Research)

Official(s) and/or principal investigator(s):
Hakan Oral, MD, Principal Investigator, Affiliation: University of Michigan
Fred Morady, MD, Study Chair, Affiliation: University of Michigan

The purpose of this study is to determine the long-term efficacy of radiofrequency catheter ablation in patients with chronic atrial fibrillation.

Official title: Randomized Comparison of Radiofrequency Catheter Ablation Vs. Antiarrhythmic Therapy With Amiodarone for Maintaining Sinus Rhythm in Patients With Chronic Atrial Fibrillation

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Freedom from atrial fibrillation and atrial flutter in the absence of antiarrhythmic drug therapy at 1 year.

Secondary outcome:

incidence of complications

changes in left atrial diameter

changes in left ventricular ejection fraction

changes in symptom severity

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

San Raffaele Hospital, Milan, Italy

University of Michigan Health System, Ann Arbor, Michigan 48109, United States

Starting date: November 2002
Ending date: February 2005
Last updated: January 3, 2006