AtriCure launches AtriClip trial

AtriCure (NSDQ:ATRC) said today that it’s launching a clinical trial of its AtriClip left atrial appendage closure device, aiming to show whether the device reduces the incidence of post-operative atrial fibrillation after cardiac surgery to repair a structural heart defect.

West Chester, Ohio-based AtriCure said the 1st patient in the 1-year Atlas trial was enrolled at PinnacleHealth Hospitals in Harrisburg, Pa. The study, which is slated to enroll up to 2,000 patients with a high risk of developing POAF, is designed to compare treatment with AtriClip in conjunction with a heart defect repair procedure to patients who undergo heart defect repair alone. It’s also designed to evaluate healthcare resource utilization between the 2 groups, AtriCure said.

“This is a very important study that will help us evaluate how left atrial appendage management can improve care for cardiac surgery patients,” president & CEO Michael Carrel said in prepared remarks. “Studies have shown that the incidence of POAF in patients undergoing cardiac surgery remains high in spite of numerous attempts to drive this complication of surgery down. This study will help us determine if a better care path exists for these at-risk patients with the ultimate goal of improving patient care and decreasing healthcare costs.”

“Clinical equipoise exists between effective LAA exclusion at the time of cardiac surgery vs prophylactic anti-coagulation of POAF in patients at elevated risk of major bleeding,” added Dr. Basel Ramlawi of the Valley Health System/Winchester Medical Center. “The Atlas trial has the potential to directly impact clinical practice for hundreds of thousands of cardiac surgical patients by answering this question.”

“It is an honor and privilege for our team at Pinnacle to be part of this highly important trial and enroll the first patient,” said PinnacleHealth’s Dr. Mubashir Mumtaz, who performed the 1st procedure in the study. “It demonstrates our partnership and commitment in understanding the importance of left atrial appendage management in cardiac surgery patients.”

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