AtriCure Receives FDA Approval For Pivotal Study to Enroll Non-Paroxysmal Afib Patients

AtriCure, Inc., a leading innovator in surgical treatments for atrial fibrillation (Afib) and left atrial appendage management (LAAM), announced it has received approval for an Investigational Device Exemption from the U.S. Food and Drug Administration (FDA) to begin enrollment in the Dual Epicardial and Endocardial Procedure (DEEP) clinical trial. The DEEP trial is 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.

The study is designed to evaluate the safety and efficacy of the DEEP approach in treating non-paroxysmal (also called persistent, long-standing persistent and permanent) 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 (outside the heart) ablation and endocardial (inside the heart) catheter-based ablation. The primary effectiveness endpoint is freedom from Afib and freedom of Class I or III antiarrhythmic drug therapy. AtriCure has FDA approval to enroll 220 subjects at up to 25 sites in the U. S. and internationally.

“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.”

“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.”

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.

“I think the combined surgical-catheter ablation approach is a promising treatment for atrial fibrillation,” said Dr. Wang. “That’s why I’m really excited about being involved with this important study.”

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.

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 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.

“The DEEP procedure is an integrated and minimally-invasive approach to resistant atrial fibrillation combining the strengths of multi-specialty ablation techniques. I am excited about the DEEP trial and evaluating patients with non-paroxysmal Afib for whom the outcome of traditional endocardial ablation has been challenging,” said Dr. Khoynezhad.

More than 2.7 million Americans are living with Afib, a cardiac rhythm disorder that increases in prevalence with age. Afib is associated with a five-fold increased risk of stroke. It is responsible for nearly 100,000 deaths, and adds $26 billion in expense to the U.S. healthcare system, each year. ¹

More information can be found at www.AtriCure.com.

About AtriCure

AtriCure, Inc. is a medical device company providing innovative atrial fibrillation (Afib) solutions designed to produce superior outcomes that reduce the economic and social burden of atrial fibrillation. 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. AtriCure’s AtriClip left atrial appendage management (LAAM) exclusion device is the most widely sold device worldwide that’s indicated for the occlusion of the left atrial appendage. The company believes cardiothoracic surgeons are adopting its ablation and LAAM devices for the treatment of Afib and reduction of Afib related complications such as stroke. Afib affects more than 33 million people worldwide.² For more information visit AtriCure.com.

1 January, C., Wann S., Alpert J., Calkins H., Cleveland J., Cigarroa J., Conti J., Ellinor P., “2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society.” Circulation. 2014 March.

2 Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, et al., “Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study.” Circulation. 2014 Feb 25; 129 (8):837-47.