Feature | May 14, 2013

Study Compares Multidisciplinary Convergent Procedure to Endocardial Catheter Ablation to Treat AF

The CONVERGE IDE clinical trial may set a new standard of care in AF ablation

The EPi-Sense-AF Guided Coagulation System.


May 14, 2013 — nContact Inc. said it received conditional approval for an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin enrollment in the CONVERGE trial, a multicenter, prospective, randomized study evaluating patients with symptomatic persistent atrial fibrillation (AF). AF is the most common cardiac arrhythmia, a condition that disrupts the ability of the atria (upper chambers of the heart) to beat regularly and pump blood efficiently. The CONVERGE study, designed to investigate the  epicardial/endocardial Convergent Procedure, combines the cardiac ablation expertise, techniques, and technologies of both electrophysiologists and cardiothoracic surgeons.

"The Convergent Procedure may set a new standard of care in AF ablation," said Kenneth C. Civello Jr., M.D., MPH, of Our Lady of the Lake Hospital, Baton Rouge, La. "This pioneering clinical study will evaluate the unmet need of the large persistent AF patient population for whom conventional endocardial ablation has been limited."

The multidisciplinary Convergent Procedure is performed as a single procedure in the electrophysiology lab. The epicardial component of the procedure is completed with no chest incisions, using the proprietary transdiaphragmatic approach that requires a 2 cm incision in the abdomen, providing the surgeon direct visualization to create lesions across the atrium.

"The convergent procedure is the least invasive option among multidisciplinary ablation techniques; there is no chest violation, no heart dissection, and no lung deflation," said Peter Walts, M.D., of St. Vincent Medical Group, Indianapolis, Ind. "By providing direct visualization and closed-chest access to the posterior left atrium, the convergent procedure may address major limitations experienced in traditional endocardial ablation."

The CONVERGE trial 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.

For more information: www.ncontactinc.com

 


Related Content

News

May 15, 2024 —CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for cardiac ...

Home May 15, 2024
Home
News

May 13, 2024 — Innovative Health, Inc. announced that recent growth in single-use device reprocessing has delivered ...

Home May 13, 2024
Home
News

October 10, 2023 — Axon Therapies, a private company focused on addressing a root cause of heart failure, announced 6 ...

Home October 10, 2023
Home
News

August 9, 2023 — Boston Scientific Corporation announced it has received U.S. Food and Drug Administration (FDA) ...

Home August 09, 2023
Home
News

January 31, 2023 —Imricor, a global leader in real-time interventional cardiac magnetic resonance (iCMR) ablation ...

Home January 31, 2023
Home
News

December 21, 2022 — Stereotaxis, a global leader in robotic technologies for the treatment of cardiac arrhythmias ...

Home December 21, 2022
Home
News

October 24, 2022 — Acutus Medical, Inc, an arrhythmia management company focused on improving the way cardiac ...

Home October 24, 2022
Home
News

May 13, 2022 — Acutus Medical, an arrhythmia management company focused on improving the way cardiac arrhythmias are ...

Home May 13, 2022
Home
News

May 4, 2022 – Stereotaxis, the global leader in innovative robotic technologies for the treatment of cardiac arrhythmias ...

Home May 04, 2022
Home
News

April 5, 2021 — Acutus Medical today announced initial U.S. enrollments in the company’s AcQForce Flutter ...

Home April 05, 2021
Home
Subscribe Now