Eighteen-Month LeAAPS Trial Enrollment Completed

After more than two years, AtriCure Inc. has completed enrollment in the LeAAPS (left atrial appendage exclusion for prophylactic stroke reduction), having recruited 6,500 patients across 137 centers globally.

LeAAPS is a blinded, superiority, investigational device exemption (IDE) study is evaluating the AtriClip LAA Exclusion System for preventing ischemic stroke and systemic arterial embolism in cardiac surgery patients without Afib history—a large and often underserved population at elevated risk for these events. It is estimated that well over 1 million cardiac surgery procedures occur annually and more than 70% of these patients have no history of Afib before surgery.

“The LeAAPS trial is a bold clinical evidence initiative that demonstrates AtriCure’s commitment to improving care for cardiac surgery patients,” AtriCure President/CEO Michael Carrel said. “The rapid pace of trial enrollment is a testament to the team of clinical trial investigators and broader clinician interest in changing the standard of care in cardiac surgery. LeAAPS presents an opportunity to drive improved long-term outcomes for patients while significantly expanding our market leadership through the increased use of our AtriClip devices.”

Results of AtriCure’s prospective LeAAPS trial are expected to inform clinical practice and treatment guidelines for stroke prevention, using AtriClip platform technology, in patients undergoing planned cardiac surgery. The randomized study will continue with five years of follow-up to assess long-term outcomes. LeAAPS is being conducted in collaboration with the Population Health Research Institute (PHRI), affiliated with McMaster University in Hamilton, Ontario. PHRI brings extensive experience in designing and executing large-scale international clinical trials.

“For decades, the medical community has sought to better understand the role of the LAA in stroke following cardiac surgery,” said Dr. Richard Whitlock, cardiothoracic surgeon at McMaster University and the trial’s global principal investigator. “LeAAPS aims to deliver definitive evidence to guide optimal care for high-risk patients without Afib who may benefit from LAA exclusion.”

AtriCure first entered the LAA management market with U.S. Food and Drug Administration (FDA) 510(k) clearance of the AtriClip System in 2010. AtriClip devices are now the most widely used LAA management device worldwide. The company plans to use LeAAPS data to support an expanded indication for stroke prevention in patients at elevated risk of ischemic stroke.

AtriCure provides technologies for treating Afib and related conditions. Electrophysiologists, cardiothoracic and thoracic surgeons worldwide use AtriCure technologies to treat Afib, reduce Afib- related complications and post-operative pain management. AtriCure’s Isolator Synergy Ablation System is the first medical device to receive FDA approval to treat persistent and long-standing persistent Afib. AtriCure’s AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE probes are cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures.