Use of Radiofrequency Ablation to Eliminate Continuous Atrial Fibrillation in Patients Undergoing Mitral Valve Surgery
|ClinicalTrials.gov Identifier: NCT00238706|
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : May 5, 2006
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Radiofrequency Catheter Ablation||Device: Radiofrequency ablation|
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 Type :||Interventional (Clinical Trial)|
|Intervention Model:||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|
- The primary outcome endpoint was the presence of SR at 12 months
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238706
|Study Director:||Nilesh Samani, FRCP||University of Leicester, Dept of Cardiology|