Investigational Device Evaluation of the WATCHMAN Elite™ Left Atrial Appendage Closure Technology
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.
• The subject is of legal age to participate in the study per the laws of their respective geography.
• 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).
• 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.
• The subject is deemed to be suitable for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy following WATCHMAN Elite Device implant.
• The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.
• The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
• The subject is able and willing to return for required follow-up visits and examinations.