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

• •50 years of age or older.
• •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.