Clinical Research Directory

Inclusion Criteria: * Age ≥ 65 years * Age \<65 years and age ≥ 60 years with high surgical risk after combing STS Risk Estimate, Katz activities of Daily Living, major Organ System Dysfunction and Procedure-Specific Impediment; * Severe, bicuspid aortic stenosis: * Mean gradient ≥40 mmHg * Maximal aortic valve velocity ≥4.0 m/sec * Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2) * NYHA classification ≥ II; * Type 0, type 1 (Sievers classification) by MDCT * Perimeter-derived annulus diameter ranges from 20.0 mm to 29.0 mm; * Transfemoral TAVR * The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site. Exclusion Criteria: * Any contra-indication for Self-expanding bioprosthetic aortic valve deployment * Leukopenia (WBC \< 3000 cell/mL), acute anemia (Hgb \< 9 g/dL), Thrombocytopenia (Plt\< 50,000 cell/mL). * Active sepsis, including active bacterial endocarditis with or without treatment; * Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment \[(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)\]. * Stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure. * Estimated life expectancy \< 12 months (365 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease. * Any Emergent surgery required before TAVR procedure. * A known hypersensitivity or contraindication to any of the following that cannot be adequately medicated:aspirin or heparin (HIT/HITTS) and bivalirudin, clopidogrel,Nitinol (titanium or nickel),contrast media * Gastrointestinal (GI) bleeding that would preclude anticoagulation. * Subject refuses a blood transfusion. * Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits). * Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams. * Currently participating in an investigational drug or another device study (excluding registries). * Hypertrophic cardiomyopathy (HCM with myocardium more than 1.5cm without an identifiable cause) with obstruction (HOCM). * Echocardiographic evidence of intracardiac mass, thrombus or vegetation. * Severe mitral stenosis amenable to surgical replacement or repair. * Aortic valve type cannot be determined (Sievers classification). * Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma \[especially if thick (\> 5 mm), protruding or ulcerated\] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe"unfolding" and horizontal aorta(Annular Angulation\>70°). * Ascending aorta diameter \> 50 mm. * Aortic or iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath. * Patient is considered high risk for TAVR by CT corelab, including coronary obstruction, annular rupture and other severe TAVR-Related complications. * Previous pacemaker implantation.