Boston Scientific Corporation
The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN Elite Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation who are eligible for anticoagulation therapy to reduce the risk of stroke.
This study is a prospective, non-randomized, multicenter investigation to establish the safety and effectiveness of the WATCHMAN Elite LAAC Device for subjects with non-valvular atrial fibrillation who are suitable for anticoagulation therapy to reduce the risk of stroke but who have a rationale to seek a non-pharmacologic alternative.
Inclusion Criteria: 1. The subject is of legal age to participate in the study per the laws of their respective geography. 2. The subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve). 3. The subject has an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy. 4. The subject is deemed to be suitable for the defined protocol pharmacologic regimen of…
WATCHMAN Elite LAAC Device Implantation
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