Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China

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-0 or Type-2 bicuspid valve, 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: a. bicuspid aortic valve with an ascending aorta diameter ≥ 45mm b. tricuspid 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.