AtriCure (Nasdaq:ATRC) announced today that it treated the first patient in its left atrial appendage exclusion for stroke prevention (LeAAPS) trial.
U.S. co-principal investigator Dr. Marc Gerdisch treated the first patient at Franciscan St. Francis Heart Center in Indianapolis.
The prospective, randomized, blinded investigational device exemption (IDE) trial will evaluate the safety and effectiveness of AtriClip. Mason, Ohio–based AtriCure designed AtriClip for the prevention of ischemic stroke or systemic arterial embolism. The LAA exclusion system treats cardiac surgery patients at elevated risk for these events with no history of AFib.
AtriCure said it expects the trial to enroll up to 6,500 patients across up to 250 centers worldwide. This would make it the largest randomized clinical trial for surgical LAA exclusion, the company said.
“The LeAAPS trial is a landmark study to evaluate the prophylactic use of AtriClip devices for stroke reduction in cardiac surgery patients without a preoperative Afib diagnosis, laying the groundwork for a new frontier in stroke prevention,” said Michael Carrel, president and CEO of AtriCure.
Carrel added that the trial presents a “substantial opportunity” to leverage AtriClip for better long-term outcomes. It also allows AtriCure to expand its markets.
AtriCure plans to use LeAAPS trial results to expand the label indications for the use of AtriClip. That could include stroke prevention in patients with an elevated risk of ischemic stroke events.
“LeAAPS is one the largest randomized controlled trials in cardiac device history, and we expect it will establish a new standard of care for patients undergoing cardiac surgery,” said Dr. Richard Whitlock, a cardiothoracic surgeon at McMaster University and global principal investigator for the trial.