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Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Radiofrequency catheter ablation
Amiodarone and cardioversion
Sponsored by
University of Michigan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, catheter ablation, amiodarone, cardioversion

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Health System
  • San Raffaele Hospital

Outcomes

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

Full Information

First Posted
January 3, 2006
Last Updated
June 2, 2015
Sponsor
University of Michigan
Collaborators
San Raffaele University Hospital, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT00272636
Brief Title
Radiofrequency Catheter Ablation for 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 Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Michigan
Collaborators
San Raffaele University Hospital, Italy

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, catheter ablation, amiodarone, cardioversion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Radiofrequency catheter ablation
Intervention Type
Drug
Intervention Name(s)
Amiodarone and cardioversion
Primary Outcome Measure Information:
Title
Freedom from atrial fibrillation and atrial flutter in the absence of antiarrhythmic drug therapy at 1 year.
Secondary Outcome Measure Information:
Title
incidence of complications
Title
changes in left atrial diameter
Title
changes in left ventricular ejection fraction
Title
changes in symptom severity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakan Oral, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fred Morady, MD
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
San Raffaele Hospital
City
Milan
Country
Italy

12. IPD Sharing Statement

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Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation

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