Evaluating Safety and Long-Term Results of Sapien 3 Transcatheter Aortic Valve Replacement in Chinese Patients Aged 50 to 70 With Severe Aortic Valve Stenosis

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and durability of Sapien 3 transcatheter aortic valve replacement TAVR in younger Chinese patients aged 50 to 70 years with severe aortic stenosis, including those with Type-1 bicuspid aortic valve. This observational study addresses gaps in current knowledge, especially for patients under 65 years old, as previous data mainly focused on older or higher-risk groups. The study aims to better understand TAVR outcomes in this specific younger population. Participants will undergo the Sapien 3 TAVR procedure, performed via transfemoral access under local or general anesthesia following standard clinical practice. The study includes both retrospectively enrolled patients and prospectively enrolled patients who will receive the procedure. The procedure involves vascular access, device delivery, and deployment with monitoring for procedural success and complications. During the study, participants will be followed for up to 5 years, with evaluations including all-cause mortality, stroke, rehospitalization, device success, valve durability, paravalvular leakage, and heart function assessments. Researchers will use imaging, clinical exams, and quality-of-life questionnaires at various time points to track outcomes. Safety measures such as monitoring for complications like annular rupture, bleeding, and atrial fibrillation will also be included throughout the follow-up period.

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