a pilot study to assess watchman flx™ implants by cardiac computed tomography, magnetic resonance imaging and transesophageal echocardiography: watchman flx™ ct

Conditions: The Focus of the Study is to Reduce the Risk of Stroke and Life-threatening Bleeding Events in Patients With Non-valvular Atrial Fibrillation

Summary: 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.


Eligibility criteria:
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.