Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)

Who can take part

• Age ≥ 65 years
• Age <65 years and age ≥ 60 years with high surgical risk after combing STS Risk Estimate (≥ 8%), Katz activities of Daily Living, major Organ System Dysfunction and Procedure-Specific Impediment
• Severe, bicuspid aortic stenosis: Mean gradient ≥40 mmHg OR Maximal aortic valve velocity ≥4.0 m/sec OR Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2); if SVi <35mL/m2, low-dose dobutamine stress echocardiography is required
• NYHA classification ≥ II
• Type 0 (Sievers classification) by MDCT
• Perimeter-derived annulus diameter ranges from 20.0 mm to 26.0 mm
• Candidate for 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

Who cannot take part

• Any Emergent surgery required before TAVR procedure
• Currently participating in an investigational drug or another device study (excluding registries)
• Severe mitral stenosis amenable to surgical replacement or repair
• Previous pacemaker implantation
• 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
• 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
• 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
• 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°)
• 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
• Subject refuses a blood transfusion
• Hypertrophic cardiomyopathy (HCM with myocardium more than 1.5cm without an identifiable cause) with obstruction (HOCM)
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation
• Aortic valve type cannot be determined (Sievers classification)
• 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