Watchman FLX Pro CT Pilot Study

Exclusion Criteria

• •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.
• •Subject has eGFR \<30 mL/min (chronic kidney disease stage IV or stage V).
• •Subject is contraindicated for TEE.
• •Subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction (e.g., due to an underlying hypercoagulable state).
• •Subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 60 days after implant (including, but not limited to, cardioversion, percutaneous coronary intervention, cardiac ablation, cataract surgery, etc.).
• •Subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or TIA within the 30 days prior to enrollment.
• •Subject had a prior major bleeding event per ISTH definitions within the 30 days prior to enrollment. Lack of resolution of related clinical sequelae or planned and pending interventions to resolve bleeding/bleeding source are a further exclusion regardless of timing of the bleeding event.
• •Subject has an active bleed.
• •Subject has a reversible cause for AF or has transient AF.
• •Subject has no LAA or the LAA is surgically ligated.
• •Subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 30 days prior to enrollment.
• •Subject has a history of atrial septal repair or has an atrial septal defect/patent foramen ovale (ASD/PFO) device.
• •Subject has a known contraindication to percutaneous catheterization procedure.
• •Subject has a cardiac tumor.
• •Subject has signs/symptoms of acute or chronic pericarditis.
• •Subject has an active infection.
• •There is evidence of tamponade physiology.
• •Subject has New York Heart Association Class IV congestive heart failure at the time of enrollment.
• •Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment per study physician's discretion).
• •Subject has a documented life expectancy of less than 6 months.