AtriCure has announced the completion of enrolment in the LeAAPS clinical trial—a prospective, randomised, blinded, superiority investigational device exemption (IDE) trial evaluating the AtriClip left atrial appendage (LAA) exclusion system for the prevention of ischaemic stroke and systemic arterial embolism in cardiac surgery patients without a history of atrial fibrillation (AF).
The LeAAPS trial was initiated in January 2023, and has enrolled 6,500 patients at 137 centres across the globe.
“For decades, the medical community has sought to better understand the role of the LAA in stroke following cardiac surgery,” said Richard Whitlock (McMaster University, Hamilton, Canada), global principal investigator for the trial. “LeAAPS aims to deliver definitive evidence to guide optimal care for high-risk patients without AF who may benefit from LAA exclusion.”
An AtriCure press release notes that cardiac surgery patients with no history of AF constitute “a large and often underserved population at elevated risk for these events”. It is estimated that more than one million cardiac surgery procedures occur annually and more than 70% of these patients have no history of AF before surgery, the release adds.
According to AtriCure, results from the 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 trial 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), which is affiliated with McMaster University.
“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 chief executive officer (CEO) of AtriCure. “The rapid pace of trial enrolment 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 management market with US Food and Drug Administration (FDA) 510(k) clearance of the AtriClip system in 2010—and the company claims that, today, AtriClip is the most widely used LAA management device worldwide. AtriCure plans to use LeAAPS data to support an expanded indication for stroke prevention in patients at elevated risk of ischaemic stroke.
