Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272636
• Other study ID #: 2002-0480
• Status: Completed
• Phase: N/A
• First received: January 3, 2006
• Last updated: June 2, 2015
• Start date: November 2002
• Est. completion date: February 2005

Study information

• Verified date: January 2006
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Radiofrequency catheter ablation

Drug:
• Amiodarone and cardioversion

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milan
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	San Raffaele University Hospital, Italy

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial fibrillation and atrial flutter in the absence of antiarrhythmic drug therapy at 1 year.
Secondary	incidence of complications
Secondary	changes in left atrial diameter
Secondary	changes in left ventricular ejection fraction
Secondary	changes in symptom severity