CONVERGE trial will assess minimally-invasive AF treatment

The CONVERGE IDE trial is underway, with the first patient treated in the study comparing an endocardial and epicardial convergent procedure with endocardial ablation alone for the treatment of atrial fibrillation, according to a press release from nContact Inc.

The multicenter, prospective, randomized trial will randomize patients with symptomatic, persistent AF to an epicardial-endocardial convergent procedure, which incorporates the nContact Inc. EPi-Sense AF-guided Coagulation System with VisiTrax, or to endocardial ablation alone.

“The CONVERGE study is a randomized prospective study to determine the best interventional approach for patients with persistent AF, John R. Onufer, MD, of Virginia Cardiovascular Specialists, Levinson Heart Hospital, Richmond, Va., stated in the press release. “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.”

The primary efficacy endpoint is freedom from AF, atrial tachycardia or atrial flutter, without the need for new antiarrhythmic drugs. Reduction in AF burden and quality-of-life changes from baseline will serve as secondary endpoints. Researchers will also assess the incidence of major adverse events during the course of the study. Follow-up will be conducted for 12 months.

The convergent procedure is conducted at a single facility. Epicardial lesions are created through a 2-cm abdominal incision by a cardiothoracic surgeon, followed by endocardial lesions created by an electrophysiologist.

“The convergent procedure enables posterior left atrium isolation by providing direct visualization and closed-chest access,” Graham Bundy, MD, of Cardiothoracic Surgical Associates, Levinson Heart Hospital, Richmond, Va., stated in the release. “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.”