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): 1. Aspirin only 2. Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC) 3. DAPT
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,857
WATCHMAN FLX Pro LAAC Device Implantation
Reduced dose NOAC Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the reduced dose NOAC arm tested for non-inferiority compared to the DAPT arm
Non Inferiority
Time frame: 6 months after randomization
Aspirin Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the Aspirin arm tested for non-inferiority compared to the DAPT arm.
Non Inferiority
Time frame: 6 months after randomization
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University of Alabama Birmingham
Birmingham, Alabama, United States
Grandview Medical Center
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Arrhythmia Research Group
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Scripps Memorial Hospital
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Loma Linda University Medical Center
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...and 77 more locations