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

pros and cons of new anticoagulation therapies, anticoagulants, dabigatran, Pradaxa, novel oral anticoagulants, NOACs, rivaroxaban, Xarelto, apixaban, Eliquis
Feature | Antiplatelet and Anticoagulation Therapies| July 26, 2016 | Heidi Olson, Pharm.D
With the recent introduction of several novel oral...
Alere, INRatio PT/INR Monitor, voluntary recall, FDA
News | Blood Testing| July 12, 2016
July 12, 2016 — Following a collaborative process with the U.S. Food and Drug Administration (FDA), Alere Inc.
Abbott, FIRM-guided rotor ablation, atrial fibrillation, clinical studies, Cardiostim 2016
News | EP Mapping and Imaging Systems| July 07, 2016
July 7, 2016 — Abbott recently announced positive results from three clinical studies investigating the benefits asso
AtriCure, FROST cryoanalgesia study, William Beaumont Hospital Michigan, cryoICE system
News | Left Atrial Appendage (LAA) Occluders| July 07, 2016
AtriCure Inc. announced the first patient has been enrolled in the FROST study at William Beaumont Hospital, Dearborn,...
AtriCure, AtriClip PRO2 LAA Exclusion System, CE Mark, left atrial appendage occlusion
News | Left Atrial Appendage (LAA) Occluders| July 05, 2016
AtriCure Inc. announced that it has received CE Mark for the AtriClip PRO2 Left Atrial Appendage (LAA) Exclusion System...
News | Heart Failure| July 05, 2016
A research team has developed a new electric mesh device that can be wrapped around the heart to deliver electrical...
anabolic steroid abuse, ARVC, arrhythmia, stroke, British Cardiovascular Society conference
News | Cardiac Diagnostics| July 01, 2016
Research has already shown that taking anabolic steroids is associated with high blood pressure and an increased risk...
St. Jude Medical, CE Mark, SyncAV CRT, MultiPoint Pacing, CardioStim 2016
Technology | Cardiac Resynchronization Therapy Devices (CRT)| June 28, 2016
St. Jude Medical Inc. announced CE Mark approval and launch of SyncAV CRT software, designed to build upon the company’...
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Clinical Study| June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
atrial fibrillation, stroke risk, aspirin vs blood thinners, JACC study
News | Antiplatelet and Anticoagulation Therapies| June 24, 2016
More than 1 in 3 atrial fibrillation (AF) patients at intermediate to high risk for stroke are treated with aspirin...
Overlay Init