The first patient has been enrolled in the ATLAS (AtriClip Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures) clinical study. This study will observe the ability of the use of the AtriClip (AtriCure) device to decrease complications associated with postoperative atrial fibrillation (POAF) by focusing on those cardiac surgery patient populations at the highest risk of developing the condition.
The ATLAS study will compare the clinical impact of patients at highest risk of developing POAF to two randomised 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 utilisation between the two groups.
This observational study will evaluate the thromboembolic and haemorrhagic events of subjects diagnosed with POAF (AtriClip vs. no AtriClip) through 365 days post index procedure. The study will enrol 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 atrial fibrillation-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,” says Basel Ramlawi, chairman of the Heart and Vascular Center, Valley Health System/Winchester Medical Center, Winchester, USA. “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 honour and privilege for our team at Pinnacle to be part of this highly important trial and enrol the first patient,” says Mubashir Mumtaz, chief of Cardiovascular and Thoracic Surgery at PinnacleHealth Hospitals, who performed the first procedure in the study.