February 18, 2016 — AtriCure Inc. announced that the first patient was enrolled and treated at PinnacleHealth Hospitals in Harrisburg, Pa., in the ATLAS clinical study. This observational study explores the use of the AtriClip device to decrease complications associated with post-operative atrial fibrillation (POAF) by targeting specific cardiac surgery patient populations at the highest risk of developing POAF.
Postoperative Afib occurs in up to 30 percent of patients undergoing cardiac surgery. Research has shown that specific risk factors predict patients at greatest risk. POAF is associated with increased complications, increased reoperations and longer hospital length of stay. The ATLAS study will compare the clinical impact of patients at highest risk of developing POAF to two randomized treatment arms: surgical left atrial appendage (LAA) exclusion (using AtriClip LAA Exclusion Systems) and patients with POAF and no surgical LAA exclusion. In addition, the study will evaluate healthcare resource utilization between the two groups.
This observational study will evaluate the thromboembolic and hemorrhagic events of subjects diagnosed with POAF (AtriClip vs. no AtriClip) through 365 days post-index procedure. The study will enroll up to 2,000 patients at 20 sites who are scheduled for cardiac surgery with specific risk factors for developing new onset POAF, as well as significant risk factors for bleeding on commonly prescribed medications to decrease the risk of Afib-related stroke.
“Clinical equipoise exists between effective LAA exclusion at the time of cardiac surgery versus prophylactic anti-coagulation of POAF in patients at elevated risk of major bleeding.” said Basel Ramlawi, M.D., chairman of the Heart and Vascular Center, Valley Health System/Winchester Medical Center, Winchester, Va. “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 Mubashir Mumtaz, M.D., FACS, FACC, chief of cardiovascular and thoracic surgery at PinnacleHealth Hospitals, who performed the first procedure in the study. “It demonstrates our partnership and commitment in understanding the importance of left atrial appendage management in cardiac surgery patients.”
For more information: www.atricure.com