AtriCure (Nasdaq: ATRC) today announced the completion of enrollment in a study evaluating its AtriClip system for preventing stroke.
Investigators initiated the left atrial appendage exclusion for prophylactic stroke reduction (LeAAPS) clinical trial in January 2023. The study enrolled 6,500 patients across 137 centers around the globe.
LeAAPS, an FDA investigational device exemption (IDE) trial, evaluates the AtriClip LAA exclusion system. It looks to prevent ischemic stroke and systemic arterial embolism in cardiac surgery patients without a history of AFib. AtriCure expects results to inform clinical practice and treatment guidelines for stroke prevention by using the AtriClip platform technology in patients undergoing planned cardiac surgery.
The company expects the trial to continue with five years of follow-up to assess long-term outcomes. It hopes to use LeAAPS data to support an expanded indication for stroke prevention in patients at elevated risk of ischemic stroke.
“The LeAAPS trial is a bold clinical evidence initiative that demonstrates AtriCure’s unwavering commitment to improving care for cardiac surgery patients,” said Michael Carrel, president and CEO of AtriCure. “The rapid pace of trial enrollment is a testament to the exceptional team of clinical trial investigators and broader clinician interest in changing the standard of care in cardiac surgery. LeAAPS presents an incredible opportunity to drive improved long-term outcomes for patients while significantly expanding our market leadership through the increased use of our AtriClip devices.”
AtriCure first entered the LAA market in 2010 with AtriClip’s FDA clearance. It continues to build on that with the first uses of the latest AtriClip LAA technology coming earlier this year. The company labeled AtriClip devices as the most widely used LAA management device worldwide.
