Atrial Fibrillation Clinical Trial
Official title:
Left Atrial Radiofrequency Ablation During Mitral Valve Surgery for Continuous Atrial Fibrillation: A Prospective Randomized Clinical Trial
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.
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).
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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