Elite AF IDE Trial (Elite AF)

You may not qualify if:

• 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 known contraindication to percutaneous catheterization procedure or is contraindicated for transesophageal echocardiography (TEE) or cardiac computed tomography (CT).
• The subject has documented left ventricular ejection fraction (LVEF) \< 30%.
• The subject has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment.
• The subject has a LAA anatomy that is incompatible with the device selection requirements outlined in the Instructions for Use (IFU).
• 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 estimated glomerular filtration rate (eGFR) \<30 ml/min (chronic kidney disease stage IV or V) or is on dialysis.
• The subject has a cardiac tumor.
• The subject has signs/symptoms of acute or chronic pericarditis.
• The subject has an active infection.
• The subject has documented surgical closure of the left atrial appendage.
• The subject has a history of atrial septal repair or has an ASD/PFO device.
• +13 more criteria