Long-term Study of the SAPIEN 3 Ultra RESILIA Valve for Aortic Valve Replacement Evaluating Valve Performance and Patient Outcomes Over 10 Years

What this Trial Is About

This research investigates the long-term clinical outcomes and valve performance of the SAPIEN 3 Ultra RESILIA S3UR valve in patients with severe aortic stenosis undergoing transfemoral transcatheter aortic valve replacement TAVI. The study focuses on the durability of the valve over a 10-year period, especially given the increasing use of TAVI in younger patients with longer life expectancy. The trial aims to understand both early safety and long-term valve structural changes that may lead to valve failure. Participants will undergo elective transfemoral TAVI using the S3UR valve on their native aortic valve. The study tracks clinical outcomes, device success, and valve durability through scheduled follow-ups over 10 years. Assessments include evaluation of early safety within 1 to 3 months, and bioprosthetic valve failure and structural deterioration at intervals up to 10 years post-procedure. Throughout the study, participants will attend follow-up visits to monitor valve performance using hemodynamic measurements, patient-reported outcomes, and clinical event tracking. Safety events such as stroke, bleeding, and other complications are also assessed. The research team will review valve failure rates and valve function over time to evaluate long-term performance, with participant involvement lasting up to 10 years after the procedure.

Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve