Elite AF IDE Trial (Elite AF)

Ki vehet részt

• The subject is of legal age to participate in the study per the laws of their respective geography
• The 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)
• The subject has an appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy
• The subject is deemed to be suitable for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy following WATCHMAN Elite Device implant
• The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females
• The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial
• The subject is able and willing to return for required follow-up visits and examinations

Ki nem vehet részt

• The subject has documented surgical closure of the left atrial appendage
• The subject had a prior procedure with any commercial LAAC device that was either aborted or unsuccessful
• The subject is contraindicated to oral short-term anticoagulation post-implant
• The subject is contraindicated to Aspirin and P2Y12 inhibitor
• The subject has an active bleed, or the subject has a major bleeding event per ISTH definitions within the 90 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
• The subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 90 days prior to enrollment
• The subject has a documented myocardial infarction (MI) as either a non-ST elevation MI (NSTEMI) or an ST-elevation MI (STEMI), with or without intervention, within 90 days prior to enrollment
• The subject had or is planning to have any cardiac or non-cardiac invasive or surgical procedure within 30 days prior to or 60 days after the WATCHMAN Elite Device implant (including, but not limited to: cardioversion, percutaneous coronary intervention (PCI), cataract surgery, endoscopy, etc.)
• The subject had cardiac ablation within the 60 days prior to or plans to have a cardiac ablation within 60 days after the WATCHMAN Elite implant
• The subject has intracardiac thrombus, LAA sludge (gelatinous, non-adherent, intracavitary echo-density more layered than dense spontaneous echo contrast (SEC) seen continuously throughout cardiac cycle) or dense SEC visualized by TEE prior to device implant
• The subject has a known contraindication to percutaneous catheterization procedure or is contraindicated for transesophageal echocardiography (TEE) or cardiac computed tomography (CT)
• The subject has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment
• The subject has a known hypercoagulability disorder, mechanical heart valve in any position, known amyloid cardiomyopathy, or recurrent deep vein thrombosis (DVT)
• The subject has known history of complex atheroma with mobile plaque of the descending aorta and/or aortic arch
• The subject has a cardiac tumor
• The subject has an active infection
• The subject has a history of atrial septal repair or has an ASD/PFO device
• The subject requires long-term anticoagulation therapy for reason other than AF-related stroke risk reduction or requires chronic P2Y12 inhibitor therapy
• The subject has documented left ventricular ejection fraction (LVEF) < 30%
• The subject has estimated glomerular filtration rate (eGFR) <30 ml/min (chronic kidney disease stage IV or V) or is on dialysis
• Platelet count ≤ 100,000/μL; Pre-procedure Imaging Anatomical Exclusion Criteria:
• The subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment upon study physician's discretion)
• The subject has a documented life expectancy of less than 2 years
• The subject is currently enrolled, or plans to enroll, in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility, regardless of type of co-enrollment being proposed
• The subject has a LAA anatomy that is incompatible with the device selection requirements outlined in the Instructions for Use (IFU)
• The subject has signs/symptoms of acute or chronic pericarditis
• The subject has a LAA anatomy that is incompatible with the device selection requirements outlined in the Instructions for Use (IFU)
• The subject has an existing pericardial effusion with a circumferential echo-free space > 5mm, a significant mitral valve stenosis (i.e., MV area <1.5 cm2), and/or there is evidence (clinically or echocardiographically) of tamponade physiology
• The subject has a high-risk patent foramen ovale (PFO) with an atrial septal aneurysm excursion > 15mm or length > 15mm