Use of Radiofrequency Ablation to Eliminate Continuous Atrial Fibrillation in Patients Undergoing Mitral Valve Surgery

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Radiofrequency Catheter Ablation

• Registration Number: NCT00238706
• Lead Sponsor: University Hospitals, Leicester

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).

Study Timeline

• Study Start: 2001-12
• Study Completion: 2004-11
• Status Verified: 2005-10
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-13
• Last Update Submitted: 2006-05-04
• Last Update Posted: 2006-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome endpoint was the presence of SR at 12 months

Secondary Outcome Measures

Name	Time	Method
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).