Clinical Research Directory

Inclusion Criteria: * 50 years of age or older. * Physicians decide to use ABCS bicuspid sizing approach for the subjects. * Severe AS, defined as follows: * a) For symptomatic patients: * i) Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mm Hg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest * b) For asymptomatic patients: * i) Very severe AS with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mm Hg by transthoracic echocardiography at rest, OR * ii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mm Hg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR * iii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction \<50%. * Type-0 bicuspid aortic valve anatomy confirmed by multi-detector computed tomography (MDCT). * The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits. * Adequate iliofemoral access and acceptable level of vessel calcification and tortuosity for safe device implant. * The study patient has provided written informed consent. Exclusion Criteria: * Any of the following: a. no calcification; b. challenging calcification based on physician's experience and discretion (Case Review Board would decide whether to exclude challenging calcification cases) * Aortic valve is a congenital unicuspid valve, congenital Type-1 or Type-2 bicuspid valve, tricuspid or quadricuspid valve * Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR * Evidence of an acute myocardial infarction ≤ 1 month (30 days), with evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia * Need for open heart surgery (including severe aortic regurgitation, mitral regurgitation or stenosis, or tricuspid regurgitation, congenital heart disease, AF, complex coronary artery disease) * Aortic disease: bicuspid aortic valve with an ascending aorta diameter ≥50mm * Pre-existing mechanical or bioprosthetic valve in any position * Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit * Emergency interventional/surgical procedures within 30 days of the valve implant procedure * Hypertrophic cardiomyopathy with or without obstruction * Ventricular dysfunction with LVEF \< 30% * Cardiac imaging (echo, CT, and/or MRI) evidence of ventricular mass, thrombus or vegetation * Inability (including allergy) to heparin, iodine contrast agent, warfarin or NOAC, aspirin or clopidogrel * Stroke or transient ischemic attack (TIA) within 180 days of the valve implant procedure * Renal replacement therapy at the time of screening * Severe lung disease (FEV1 \< 50% predicted) or currently on home oxygen * Estimated life expectancy \< 24 months * Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. Observational studies are not considered exclusionary.