LeAAPS

Official Title

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) Trial

Study Purpose

To evaluated safety and effectiveness of prophylactic LAAE for the prevention of ischemic stroke or systemic embolism in subjects undergoing cardiac surgery who have risk factors for AF and ischemic stroke

Diagnosis

Planned and clinically indicated cardiac surgical procedure requiring opening of the pericardium; Significant left atrium enlargement or elevated NT-proBNP

Eligibility

Exclusion

• Clinically significant atrial fibrillation or atrial flutter
• Prior procedure involving opening the pericardium or entering the pericardial space
• Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
• Planned cardiac surgical procedure
• Patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices
• Active endocarditis
• Active systemic infection at the time of cardiac surgery requiring antibiotics, including known SARS-CoV2 infections regardless of symptoms
• Known allergy to nickel sensitivity

Intervention

Prospective, randomized (1:1), multicenter, blinded, event-driven superiority trial 

Treatment ARM: Left Atrial Appendage Exclusion (LAAE) using AtriClip concomitant to and at the time of planned cardiac surgery versus Control ARM: No LAAE concomitant to and at the time of planned cardiac surgery