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Clinical Trials/NCT00238706
NCT00238706
Completed
Not Applicable

Left Atrial Radiofrequency Ablation During Mitral Valve Surgery for Continuous Atrial Fibrillation: A Prospective Randomized Clinical Trial

University Hospitals, Leicester0 sitesDecember 2001

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
University Hospitals, Leicester
Primary Endpoint
The primary outcome endpoint was the presence of SR at 12 months
Status
Completed
Last Updated
20 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 2001
End Date
November 2004
Last Updated
20 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospitals, Leicester

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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).

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