The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
949
Treatment with a WATCHMAN FLX Pro Left Atrial Appendage Closure Device
Primary Efficacy Endpoint: The Rate of Device Leak >5 mm at 45-day Post-Implant TEE for the Primary Analysis Subjects
Incomplete seal with peri-device gap \> 5mm in the primary analysis subset implanted patients with 45-day TEE imaging (as assessed by the core lab).
Time frame: 45 days
Primary Safety Endpoint: Composite Rate of All-cause Mortality, All Stroke, Systemic Embolism, and Major Bleeding for the Primary Analysis Subjects
Composite CEC-adjudicated all-cause mortality, all stroke, systemic embolism, and major bleeding in the Intention to Treat (ITT) population at 6 months.
Time frame: 6 months
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