Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00272636
Recruitment Status : Completed
First Posted : January 6, 2006
Last Update Posted : June 3, 2015
San Raffaele University Hospital, Italy
Information provided by:
University of Michigan

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: Radiofrequency catheter ablation Drug: Amiodarone and cardioversion Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Radiofrequency Catheter Ablation vs. Antiarrhythmic Therapy With Amiodarone for Maintaining Sinus Rhythm in Patients With Chronic Atrial Fibrillation
Study Start Date : November 2002
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Secondary Outcome Measures :
  1. incidence of complications
  2. changes in left atrial diameter
  3. changes in left ventricular ejection fraction
  4. changes in symptom severity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00272636

United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
San Raffaele Hospital
Milan, Italy
Sponsors and Collaborators
University of Michigan
San Raffaele University Hospital, Italy
Principal Investigator: Hakan Oral, MD University of Michigan
Study Chair: Fred Morady, MD University of Michigan Identifier: NCT00272636     History of Changes
Other Study ID Numbers: 2002-0480
First Posted: January 6, 2006    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: January 2006

Keywords provided by University of Michigan:
atrial fibrillation
catheter ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors