In China, bicuspid aortic valve (BAV) represents a significantly high proportion of the transcatheter aortic valve replacement (TAVR) population. The application of TAVR in patients with BAV is challenging due to complex anatomy. To date, no prospective study has evaluated the Sapien 3 TAVR in patients with Type-0 BAV.
Age ≥50 years, and after thorough physician-patient discussion and shared decision-making, willing to undergo or accept TAVR.
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.
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)
severe symptomatic aortic valve stenosis (AS) patients with type-0 bicuspid anatomy
Cohort
Prospective
Transcatheter Aortic Valve Replacement
DeviceTranscatheter Aortic Valve Replacement for patients with Type-0 bicuspid aortic stenosis.
The composite of all-cause mortality, stroke, or rehospitalization
The composite of all-cause mortality, stroke, or rehospitalization
The composite of all-cause mortality, stroke, or rehospitalization
The composite of all-cause mortality, stroke, or rehospitalization
The composite of device success
The composite of device success at 30 days comprising the following: freedom from mortality, successful access, delivery of the device, and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication, intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, and less than moderate aortic regurgitation), according to the VARC-3 definition
Annular rupture
Annular rupture
Paravalvular leakage
Paravalvular leakage
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Chinese Academy of Medical Sciences, Fuwai Hospital
Lead sponsor
Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
Collaborator
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