WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Alternative Post-Implant Monotherapy
The WATCHMAN Implant is an alternative for Atrial fibrillation (AF) patients who cannot tolerate long-term blood thinner medication. Typically, after the WATCHMAN procedure, a doctor will prescribe an antiplatelet, aspirin or blood thinnermedication. The medication will help avoid blood clots to form while new tissue is growing over the device.In this trial, the doctor will prescribe based on the randomization to either a single drug or several drugs tosupport the healing process. The trial will evaluate which option can help to reduce stroke and bleeding risk. Participants in the study will be randomly assigned to one of the following groups: Group 1 will receive a non-vitamin K antagonist oral anticoagulation (NOACs). The NOACs used in this study are Eliquis® (apixaban) or Xarelto® (rivaroxaban) at lower doses than usual. Group 2 will receive aspirin. Group 3 will receive a dual-antiplatelet therapy (DAPT), which is aspirin plus Plavix® (clopidogrel). The objective of this study is to demonstrate the safety and efficacy of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following implant with the WATCHMAN FLX Pro device.
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