HANGZHOU Solution in Bicuspid AS Undergoing TAVR

Exclusion Criteria22

• 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.