Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation

This study has been completed.
Sponsor:
Collaborator:
San Raffaele University Hospital, Italy
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00272636
First received: January 3, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
San Raffaele University Hospital, Italy
Investigators
Principal Investigator: Hakan Oral, MD University of Michigan
Study Chair: Fred Morady, MD University of Michigan
  More Information

No publications provided

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

Keywords provided by University of Michigan:
atrial fibrillation
catheter ablation
amiodarone
cardioversion

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on August 28, 2014