Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation

This study has been completed.

First Received: January 3, 2006 No Changes Posted

Sponsor:	University of Michigan, Section of Electrophysiology (Arrhythmia Research)
Collaborator:	Dept of Electrophysiology, San Raffaele University Hospital, Milan, Italy
Information provided by:	University of Michigan, Section of Electrophysiology (Arrhythmia Research)
ClinicalTrials.gov Identifier:	NCT00272636

Purpose

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

Condition	Intervention
Atrial Fibrillation	Procedure: Radiofrequency catheter ablation Drug: Amiodarone and cardioversion

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Comparison of Radiofrequency Catheter Ablation Vs. Antiarrhythmic Therapy With Amiodarone for Maintaining Sinus Rhythm in Patients With Chronic Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Amiodarone hydrochloride Amidox Amiodarone

U.S. FDA Resources

Further study details as provided by University of Michigan, Section of Electrophysiology (Arrhythmia Research):

Primary Outcome Measures:

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

Secondary Outcome Measures:

incidence of complications
changes in left atrial diameter
changes in left ventricular ejection fraction
changes in symptom severity

Estimated Enrollment:	140
Study Start Date:	November 2002
Estimated Study Completion Date:	February 2005

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272636

Locations

United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Italy
San Raffaele Hospital
Milan, Italy

Sponsors and Collaborators

University of Michigan, Section of Electrophysiology (Arrhythmia Research)

Dept of Electrophysiology, San Raffaele University Hospital, Milan, Italy

Investigators

Principal Investigator:	Hakan Oral, MD	University of Michigan
Study Chair:	Fred Morady, MD	University of Michigan

More Information

No publications provided

Study ID Numbers:	2002-0480
Study First Received:	January 3, 2006
Last Updated:	January 3, 2006
ClinicalTrials.gov Identifier:	NCT00272636 History of Changes
Health Authority:	United States: Institutional Review Board

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

atrial fibrillation
catheter ablation
amiodarone
cardioversion

Additional relevant MeSH terms:

Vasodilator Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Agents
Amiodarone
Pharmacologic Actions

Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Atrial Fibrillation
Anti-Arrhythmia Agents
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 04, 2010