WATCHMAN FLX™ CT Study

A Pilot Study to Assess WATCHMAN FLX™ Implants by Cardiac Computed Tomography, Magnetic Resonance Imaging and Transesophageal Echocardiography: WATCHMAN FLX™ CT

WATCHMAN FLX™ CT is a prospective, single-arm, single-center, post-market investigation to assess device tissue coverage in subjects with non-valvular atrial fibrillation (AF) who receive the WATCHMAN FLX device to reduce the risk of stroke. Serial advanced imaging modalities such as CT and TEE will be used.

Inclusion Criteria:

• Subject is of legal age to participate in the study per the laws of their respective geography.
• 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 a WATCHMAN FLX device.
• Subject is deemed suitable for the protocol-defined pharmacologic regimen.
• 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 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 transient ischemic attack (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.