AtriCure Announces the First Patient Treated in the LeAAPS™ Clinical Trial
AtriCure, Inc. has initiated the LeAAPS clinical trial to assess the safety and effectiveness of its AtriClip® LAA Exclusion System for stroke prevention in cardiac surgery patients. The trial, involving up to 6,500 patients across 250 centers worldwide, is notable for being the largest randomized trial in surgical LAA exclusion. The goal is to establish new treatment protocols for patients at risk of ischemic stroke. The AtriClip System is recognized as a leading device in LAA management. CEO Michael Carrel emphasized the trial's potential to enhance patient outcomes and expand market opportunities.
- Initiation of LeAAPS clinical trial for AtriClip LAA Exclusion System aimed at stroke prevention.
- Largest randomized trial for surgical LAA exclusion, enrolling up to 6,500 patients.
- Potential to set new treatment guidelines for patients undergoing cardiac surgery.
- AtriClip System is the most widely used device in LAA management, suggesting strong market position.
- None.
Trial will evaluate the safety and effectiveness of the AtriCure AtriClip® Left Atrial Appendage Exclusion System for stroke prevention in cardiac surgery patients
LeAAPS is a prospective, randomized, blinded, superiority, investigational device exemption (IDE) clinical trial to evaluate the safety and effectiveness of the AtriClip® LAA Exclusion System for the prevention of ischemic stroke or systemic arterial embolism in cardiac surgery patients at elevated risk for these events and with no history of Afib, which represents a significant proportion of the market. The trial will enroll up to 6,500 patients at up to 250 centers worldwide, making it the largest randomized clinical trial for surgical LAA exclusion. LeAAPS is intended to inform and better define clinical practice and treatment guidelines for stroke prevention in patients undergoing planned cardiac surgery with an elevated risk of ischemic stroke and systemic embolism.
“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
The trial will be completed in collaboration with the
“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.
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