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

AtriCure Inc. 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, 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 company claims.

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 (Afib). The DEEP approach uses the 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 control.

In the DEEP study, the cardiac surgeon and EP work together 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 executives noted in a news release. AtriCure has FDA approval to enroll 220 subjects at up to 25 sites in the United States and internationally.

“We are pleased to be moving into this next phase of a pivotal trial for DEEP,” AtriCure CEO Mike Carrel said. “Our goal is to start the Institutional Review Board process with many of the leading institutions right away. We intend to complete enrollment in mid-2017.”

The principal investigators for DEEP are Kenneth Ellenbogen, M.D., chairman of the Division of Cardiology at Virginia Commonwealth University (VCU) Pauley Heart Center (Richmond); Paul Wang, M.D., director of the Stanford Arrhythmia Service and professor of Medicine and Bioengineering, by courtesy, at Stanford University School of Medicine (California); Vigneshwar Kasirajan, M.D., chairman, Department of Surgery and Division of Cardiothoracic Surgery and professor, Department of Surgery at VCU Pauley Heart Center; and Ali Khoynezhad, M.D., professor of Cardiovascular Surgery at Cedars-Sinai Heart Institute (New York, N.Y.).

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

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

More than 2.7 million Americans are living with Afib, a cardiac rhythm disorder that increases in prevalence with age, industry statistics show. 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.

Based in West Chester, Ohio, AtriCure develops atrial fibrillation treatments. Its Synergy Ablation System is a surgical device approved for the treatment of persistent and longstanding persistent forms of Afib in patients undergoing certain open concomitant procedures.