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)
Chinese Academy of Medical Sciences, Fuwai Hospital
Lead sponsor
Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
Collaborator