AtriCure Enrolls First Patient in Randomized Multi-Center Trial Evaluating Post-Operative Afib

WEST CHESTER, Ohio.,  AtriCure, Inc., a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage management, announced today that the first patient was enrolled and treated at PinnacleHealth Hospitals in Harrisburg, Pennsylvania in the ATLAS (AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures) clinical study. This observational study explores the use of the AtriClip device to decrease complications associated with post-operative Afib (POAF) by targeting specific cardiac surgery patient populations at the highest risk of developing POAF.

Postoperative Afib occurs in up to 30% of patients undergoing cardiac surgery.⁽¹⁾ Research has shown that specific risk factors predict patients at greatest risk.⁽²⁾ POAF is associated with increased complications, increased reoperations and longer hospital length of stay.⁽³⁾ 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 is a very important study that will help us evaluate how left atrial appendage management can improve care for cardiac surgery patients,” said Michael Carrel, President and Chief Executive Officer of AtriCure. “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.”

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 vs prophylactic anti-coagulation of POAF in patients at elevated risk of major bleeding.” said Dr. Basel Ramlawi, Chairman Heart and Vascular Center, 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 Mubashir Mumtaz, MD 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.”

Source: AtriCure