AtriCure Enrolls First Two Patients in DEEP Clinical Study

West Chester, Ohio-based Atricure Inc., which makes technologies for the surgical treatment of atrial fibrillation (Afib) and left atrial appendage management, has enrolled and treated the first two patients in the Dual Epicardial and Endocardial Procedure (DEEP) clinical study. The pivotal study is the first of its kind in the United States for the treatment of persistent or longstanding persistent forms of atrial fibrillation (Afib). The patients were enrolled at trial center PinnacleHealth CardioVascular Institute in Harrisburg, Pa.

“This important study utilizes the skills of both the cardiac surgeon and electrophysiologist to establish a new standard of care for patients with persistent forms of Afib,” said Mike Carrel, president and CEO of AtriCure. “This is a significant milestone for AtriCure as we continue our advancements in the fight against Afib.”

In the DEEP study, the cardiac surgeon and electrophysiologist work as a team to perform a minimally invasive epicardial (outside the heart) surgical ablation and endocardial (inside the heart) catheter-based ablation. The primary effectiveness endpoint of the study is freedom from Afib, the most common arrhythmia, and absence of class I or III antiarrhythmic drug therapy. AtriCure received approval in November 2014 from the U.S. Food and Drug Administration to enroll 220 patients at 25 sites in the study.

Atrial fibrillation patients who have failed antiarrhythmic drug therapy and may have 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 exclude the left atrial appendage (LAA) with the Atriclip LAA exclusion system.

The first procedure in the study was performed by Mubashir Mumtaz, M.D., chief of cardiovascular and thoracic surgery at PinnacleHealth.

“We feel privileged to be part of this landmark study in our quest to find a safe and reliable treatment for millions of people affected by atrial fibrillation,” said Mumtaz. “We really believe that this trial will provide much needed insight into this disease. We are excited and feel honored to be able to enroll and treat the first two patients to kick off the trial.”

The second phase of the procedure, catheter ablation and endocardial mapping, will be performed by Michael G. Link, M.D., electrophysiologist at PinnacleHealth about 90 to 120 days after the surgical procedure.

“I am excited about DEEP because the more persistent forms of atrial fibrillation have been historically difficult to treat, with disappointing results,” said Link. “I am honored to be at the forefront of this trial which will hopefully alter the standard of care for these patients.”