WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device With Alternative Post-Implant Monotherapy
Objective
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.
Study Arms
- Experimental: Aspirin
- Active Comparator: DAPT
Eligibility
- Subject is of legal age to participate in the study per the laws of their respective geography.
- Subject is an acceptable candidate for a WATCHMAN FLX Pro device per the approved Instructions for Use.
- Subject is deemed to be suitable for all protocol defined drug regimens in the control and both test arms.
- 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.
NCT ID
NCT06521463
