The primary objective of this study is to collect real-world data on WATCHMAN FLXâ„¢ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subject is of legal age to participate in the study.
* Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve).
* Subject is clinically indicated for and is treated or attempted to be treated with a WATCHMAN FLXâ„¢ Pro device.
* Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study.
* Subject is able and willing to return for required follow-up visits and examinations.
Exclusion Criteria:
* Subject has a documented life expectancy of less than 6 months.
* Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment.
* Intracardiac thrombus is present.
* An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present.
* The LAA anatomy will not accommodate a Closure Device.
* The patient has known hypersensitivity to any portion of the device material or the individual components such that the use of the WATCHMAN FLXâ„¢ Pro Device is contraindicated.
* Any of the customary contraindications for other percutaneous catheterization procedure (e.g., patient size too small to accommodate transesophageal echocardiography (TEE) probe or required catheters) or conditions (e.g., active infection…
What they're measuring
1
Primary Efficacy Endpoint: The Rate of Device Leak >5 mm at 45-day Post-Implant TEE for the Primary Analysis Subjects
Timeframe: 45 days
2
Primary Safety Endpoint: Composite Rate of All-cause Mortality, All Stroke, Systemic Embolism, and Major Bleeding for the Primary Analysis Subjects