FDA Approves Pivotal Study to Investigate Dual Ablation Approach in Non-Paroxysmal Afib Patients

Atrial fibrillation (Afib) and left atrial appendage management (LAAM) specialist device company AtriCure, Inc., has received approval for an Investigational Device Exemption (IDE) from the U.S. FDA to begin enrollment in the DEEP trial, a prospective, multicenter, single arm, pivotal study to evaluate patients with persistent or long-standing persistent atrial fibrillation. This is the first pivotal study of its kind in the United States.

Background

Atrial fibrillation is the most common type of arrhythmia and can cause blood clots, stroke, heart failure and other heart–related complications. A patient with Afib has a high risk of stroke because the irregular heartbeat allows blood to pool in the left atrial appendage (LAA) and form clots that can travel through the body and into the brain.

AtriCure’s Synergy™ Ablation System is the first and only surgical device approved for the treatment of persistent and longstanding persistent forms of Afib in patients undergoing certain open concomitant procedures.

The Dual Epicardial and Endocardial Procedure (DEEP) clinical trial is designed to evaluate the safety and efficacy of the DEEP approach in treating non-paroxysmal atrial fibrillation. The DEEP approach utilizes the specialized skills of both the cardiac surgeon and electrophysiologist (EP) to treat more severe cases of Afib, such as non-paroxysmal, which historically have been the most difficult to treat.

In the DEEP study, the cardiac surgeon and EP work as a team to perform a minimally invasive epicardial ablation and endocardial catheter-based ablation. The primary effectiveness endpoint is freedom from Afib and freedom of Class I or III antiarrhythmic drug therapy.

Atrial fibrillation patients who have failed antiarrhythmic drug therapy and received up to two failed catheter ablations are candidates for the DEEP study, which is performed in two phases. In the first phase, the surgeon will make small incisions to perform endoscopic epicardial ablation using the AtriCure Bipolar System, and occlude the LAA with the AtriClip® LAA Exclusion System. Then about three months later, the patient will undergo an endocardial mapping and catheter ablation procedure performed by the EP.

 

The FDA approval extends to enrollment of 220 subjects at up to 25 sites in the U. S. and internationally.

Investigator/Physician comments

The principal investigators for DEEP are Dr. Kenneth Ellenbogen, Chairman of the Division of Cardiology at Virginia Commonwealth University (VCU) Pauley Heart Center; Dr. Paul Wang, Director, Stanford Arrhythmia Service, Professor of Medicine and Bioengineering, by courtesy, Stanford University School of Medicine; Dr. Vigneshwar Kasirajan, Chairman, Department of Surgery and Division of Cardiothoracic Surgery and Professor, Department of Surgery at VCU Pauley Heart Center; and Dr. Ali Khoynezhad, Professor of Cardiovascular Surgery at Cedars-Sinai Heart Institute. 

“We look forward to pioneering the multi-specialty approach where EPs will work more closely with cardiac surgeons in this dual surgical approach,” said Dr. Ellenbogen.

“The DEEP procedure combines the expertise of both the EP and cardiac surgeon and seeks to set a new standard of care for Afib ablation therapy,” said Dr. Kasirajan.

“AtriCure is embarking on this landmark trial which will bring electrophysiologists and cardiac surgeons together as a team in an effort to establish a new standard of care for patients presenting with persistent or long-standing persistent Afib, a significant risk factor for stroke,” said Dr. James L. Cox, Emeritus Evarts A. Graham Professor of Surgery at Washington University. “AtriCure is fortunate to have such a distinguished group of physicians to provide leadership for this important trial.”

Company comments

“We are pleased to be moving into this next phase of a pivotal trial for DEEP,” said Mike Carrel, chief executive officer of AtriCure. “Our goal is to start the Institutional Review Board process with many of the leading institutions right away. We intend to have our first subject enrolled in early 2015, with completion of enrollment targeted for mid-2017.”

Source: AtriCure, Inc. 

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