Objective
to compare safety and effectiveness and the rate of LAA occlusion at 45 days after implantation of Amulet LAA occluder vs. Watchman in cases with non-valvular atrial fibrillation (NVAF)
Study
multicentre, open-label, randomised controlled trial
Population
paroxysmal, persistent, or permanent NVAF with high risk of stroke or systemic embolism defined as CHADS2 score â¥2 or a CHA2DS2-VASc score of â¥3
Endpoints
safety- composite of procedure-related complications, all-cause death, or major bleeding at 12 months; Effectiveness- composite of ischemic stroke or systemic embolism at 18 months; and rate of LAA occlusion at 45 days
Conclusion
Amulet occluder was non-inferior for safety and effectiveness of stroke prevention for NVAF, and superior for LAA occlusion as compared to the Watchman device
Lakkireddy et al. Circulation. 2021;144:1543-52
