MORRISVILLE, N.C., Jan. 8, 2014 (GLOBE NEWSWIRE) -- nContact, Inc. today announced the first patient treated in the CONVERGE IDE Clinical Trial, a multicenter, prospective, randomized study evaluating patients with symptomatic persistent atrial fibrillation (AF). AF is the most common cardiac arrhythmia, estimated to affect 5.9 million people in the U.S., with a majority of patients falling into the difficult-to-treat persistent AF population. The CONVERGE Study is designed to investigate the treatment of persistent AF patients with the multidisciplinary Convergent Procedure, an epicardial-endocardial approach that utilizes the collaborative expertise and techniques of an electrophysiologist and cardiothoracic surgeon.
"The CONVERGE Study is a randomized prospective study to determine the best interventional approach for patients with persistent AF," said John R. Onufer, MD, of Virginia Cardiovascular Specialists, Levinson Heart Hospital in Richmond, VA. "Given the difficulty in maintaining normal sinus rhythm in this patient group, several ablation strategies have been employed which thus far have not proved to be durable. This study examines a novel approach of a combined endocardial and epicardial ablation set and compares it to an endocardial only ablation strategy. It is our hope that we will learn a better way to manage patients with persistent AF."
The multidisciplinary Convergent Procedure is performed as a single procedure in the electrophysiology lab. The epicardial lesions are created first under direct endoscopic visualization by a surgeon, through a 2 cm incision in the abdomen, with no chest incisions or ports. The endocardial lesions created by an electrophysiologist help confirm lesion set completeness through specialized EP diagnostics, which also predict outcomes.
"The Convergent Procedure enables posterior left atrium isolation by providing direct visualization and closed-chest access," stated Graham Bundy, MD, of Cardiothoracic Surgical Associates, Levinson Heart Hospital, Richmond, VA. "This multidisciplinary approach may address some of the major limitations of traditional endocardial-only ablation, by providing a minimally invasive approach that has no chest incisions or ports, and a standardized ablation protocol."
The CONVERGE Study will randomize patients 2:1 between nContact's epicardial-endocardial Convergent Procedure using the EPi-Sense ™-AF guided Coagulation System with VisiTrax® and standalone endocardial ablation using fluid-irrigated catheters for the treatment of persistent AF. The primary effectiveness endpoint is freedom from AF, atrial tachycardia, and atrial flutter, without the use of new antiarrhythmic drugs. Secondary effectiveness endpoints include the reduction of AF burden and changes in Quality of Life measures from baseline: patients will be followed for 12 months post-procedure. Primary and secondary safety endpoints are the incidence of major adverse events following the initial procedure and through the 12-month follow-up period.
"This commencement of the CONVERGE Study is an important milestone in our mission to set a new standard of care in persistent AF," said John Funkhouser, President of nContact. "We are pleased to be part of this unique superiority study comparing the Convergent Procedure to endocardial catheter ablation."
nContact is attending the 19th Annual International AF Symposium January 9 – 11, 2014, in Orlando, FL, Booth #917. For more information on nContact, please visit the website at www.ncontactinc.com
About nContact, Inc.
nContact's mission is to transform the underserved arrhythmia market through the advancement of less invasive ablation alternatives for cardiac arrhythmias. The Company is conducting the CONVERGE IDE Clinical Trial, the first head-to-head superiority study to evaluate the Convergent Procedure to catheter ablation in persistent atrial fibrillation. The Company's lead technology, EPi-Sense™ Coagulation System with VisiTrax®, has CE Mark approval in Europe for the coagulation of cardiac tissue in the treatment of atrial fibrillation and atrial flutter. The EPi-Sense Coagulation System with VisiTrax is indicated for endoscopic coagulation of cardiac tissue in the U.S. nContact was founded in 2005 and is headquartered in Morrisville, North Carolina, USA.
Media Contact: Kris McCulloch nContact, Inc. T (919) 655-1351