Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Objective
The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.
Study Arms
- Experimental: Treatment
- LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
- Interventions:
- Device: AtriClip LAA Exclusion System
- No Intervention: Control
- No LAAE concomitant to and at the time of planned cardiac surgery
Eligibility
- Subjects ≥ 18 years of age
- Documentation of any of the following clinical criteria:
- CHA2DS2-VASc ≥ 4 with age ≥ 65
- CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP
- CHA2DS2-VASc = 3 with age ≥ 75
- CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP
- CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated NT-proBNP
NCT ID
NCT05478304
