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Sponsors and Collaborators: |
University Hospitals, Leicester British Heart Foundation |
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Information provided by: | University Hospitals, Leicester |
ClinicalTrials.gov Identifier: | NCT00238706 |
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.
Condition | Intervention |
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Atrial Fibrillation Radiofrequency Catheter Ablation |
Device: Radiofrequency ablation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment |
Official Title: | Left Atrial Radiofrequency Ablation During Mitral Valve Surgery for Continuous Atrial Fibrillation: A Prospective Randomized Clinical Trial |
Study Start Date: | December 2001 |
Estimated Study Completion Date: | November 2004 |
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).
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | BHF PG/2001096 |
Study First Received: | October 12, 2005 |
Last Updated: | May 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00238706 |
Health Authority: | United Kingdom: Research Ethics Committee |
Radiofrequency catheter ablation Atrial fibrillation Randomized trial |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |