A Prospective, Multicenter, Observational Study Evaluating Safety and Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Replacement for Type-0 Bicuspid Aortic Valve Stenosis Patients in China

Inclusion criteria

• Age ≥50 years, and after thorough physician-patient discussion and shared decision-making, willing to undergo or accept TAVR.
• 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

• Challenging calcification based on physician's experience and discretion
• 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
• Need for open heart surgery (including severe aortic regurgitation, mitral regurgitation or stenosis, or tricuspid regurgitation, congenital heart disease, AF, complex coronary artery disease)
• 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 obstruction
• Ventricular dysfunction with LVEF < 30%
• Cardiac imaging (echo, CT, and/or MRI) evidence of ventricular mass, thrombus or vegetation
• Renal replacement therapy at the time of screening
• Estimated life expectancy < 12 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.