The US co-principal investigator Dr Marc Gerdisch treated the first patient with the system at the Franciscan St Francis Heart Center in Indianapolis, Indiana.
The prospective, randomised, blinded, superiority and investigational device exemption (IDE) clinical study is designed to assess the safety and efficacy of the AtriClip System.
It is being tested to prevent ischemic stroke or systemic arterial embolism in cardiac surgery patients who are at increased risk for these events and have no atrial fibrillation (Afib) history.
Claimed to be the largest randomised clinical study for surgical left atrial appendage (LAA) exclusion, the trial will recruit around 6,500 patients at up to 250 centres around the world.
LeAAPS is expected to help provide better practice and treatment guidelines for stroke prevention in patients with an increased ischemic stroke risk and systemic embolism who are undergoing planned cardiac surgery.
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AtriCure president and CEO Michael Carrel 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.
“We have an impressive roster of world-class physicians and hospitals that will be enrolling patients, and we see a substantial opportunity to leverage the AtriClip platform for better long-term outcomes in this patient population while expanding our markets.”
In 2010, the company received US Food and Drug Administration (FDA) 510(k) clearance for the AtriClip System.
It aims to use the results from the LeAAPS study for the expansion of the AtriClip System’s labelled indications for stroke prevention in patients with an increased risk of ischemic stroke events.