The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting.
This study is a prospective, randomized, open-label, triple-arm, multi-center trial. Subjects will be randomized 1:1:1 to one of the three therapy arms and remain on treatment through the end of study (12 months):
- Aspirin only
- Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC)
- DAPT