Use of Radiofrequency Ablation to Eliminate Continuous Atrial Fibrillation in Patients Undergoing Mitral Valve Surgery
Primary Purpose
Atrial Fibrillation, Radiofrequency Catheter Ablation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Radiofrequency ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Radiofrequency catheter ablation, Atrial fibrillation, Randomized trial
Eligibility Criteria
Inclusion Criteria: Patients requiring MV surgery with at least 6 month history of atrial fibrillation Exclusion Criteria: Patients with sick sinus syndrome Hyperthyroidism Permanent pacemaker Previous cardiac surgery
Sites / Locations
Outcomes
Primary Outcome Measures
The primary outcome endpoint was the presence of SR at 12 months
Secondary Outcome Measures
Secondary endpoints included:
patient functional status and exercise capacity
Left atrial contractility
Left atrial and left ventricular dimension and function Plasma levels of B-Type natriuretic peptide (BNP).
Full Information
NCT ID
NCT00238706
First Posted
October 12, 2005
Last Updated
May 4, 2006
Sponsor
University Hospitals, Leicester
Collaborators
British Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00238706
Brief Title
Use of Radiofrequency Ablation to Eliminate Continuous Atrial Fibrillation in Patients Undergoing Mitral Valve Surgery
Official Title
Left Atrial Radiofrequency Ablation During Mitral Valve Surgery for Continuous Atrial Fibrillation: A Prospective Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospitals, Leicester
Collaborators
British Heart Foundation
4. Oversight
5. Study Description
Brief Summary
The aim of this prospective randomized clinical trial was to evaluate the early and late outcome following left atrial radiofrequency ablation during MV surgery for the treatment of continuous atrial fibrillation and to assess the functional effects of restoration of sinus rhythm.
Detailed Description
Atrial fibrillation (AF) is a frequent and important contributor to symptoms and morbidity in patients with mitral valve (MV) disease.Radiofrequency ablation (RFA) of the left atrium (LA) during open- heart surgery has emerged as a novel surgical modality for the treatment of AF. Although RFA therapy of the LA is being increasingly offered to patients with chronic AF undergoing MV surgery, its efficacy has not been tested in the context of an adequately powered randomized study. The aim of this prospective randomized clinical trial was to evaluate the early and late outcome following left atrial RFA during MV surgery for the treatment of continuous AF and to assess the functional effects of restoration of SR.
Patients were randomized to undergo MV surgery or MV surgery plus RFA of the LA. Additional cardiac procedures were performed as required.
The primary outcome endpoint was the presence of SR at 12 months. Secondary endpoints included patient functional status and exercise capacity, LA contractility, and LA and left ventricular (LV) dimension and function and plasma levels of B-Type natriuretic peptide (BNP).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Radiofrequency Catheter Ablation
Keywords
Radiofrequency catheter ablation, Atrial fibrillation, Randomized trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Radiofrequency ablation
Primary Outcome Measure Information:
Title
The primary outcome endpoint was the presence of SR at 12 months
Secondary Outcome Measure Information:
Title
Secondary endpoints included:
Title
patient functional status and exercise capacity
Title
Left atrial contractility
Title
Left atrial and left ventricular dimension and function Plasma levels of B-Type natriuretic peptide (BNP).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients requiring MV surgery with at least 6 month history of atrial fibrillation
Exclusion Criteria:
Patients with sick sinus syndrome
Hyperthyroidism
Permanent pacemaker
Previous cardiac surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilesh Samani, FRCP
Organizational Affiliation
University of Leicester, Dept of Cardiology
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
16278360
Citation
Doukas G, Samani NJ, Alexiou C, Oc M, Chin DT, Stafford PG, Ng LL, Spyt TJ. Left atrial radiofrequency ablation during mitral valve surgery for continuous atrial fibrillation: a randomized controlled trial. JAMA. 2005 Nov 9;294(18):2323-9. doi: 10.1001/jama.294.18.2323.
Results Reference
result
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Use of Radiofrequency Ablation to Eliminate Continuous Atrial Fibrillation in Patients Undergoing Mitral Valve Surgery
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