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

Overview

Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.

Transcatheter aortic valve replacement (TAVI) has become the gold standard treatment for moderate-to-high risk elderly patients with severe symptomatic aortic stenosis. Based on the results of randomized trials including low risk patients, this treatment has been progressively applied to younger (in the sixties and seventies) patients with a low co-morbidity burden. Life expectancy in this group is expected to extend beyond 5 years from intervention in the vast majority of patients, and beyond 10 years in a high proportion. Thus, the issue of valve durability has become one of the most important aspects in the TAVI field in recent years. To date, the rates of bioprosthetic valve failure at 8-10 years after TAVI have been consistently \<10%, but some studies have shown some degree of valve structural degeneration in close to one third of the patients at 8-year follow-up. This subclinical valve degeneration before the 10-year follow-up landmark would represent the initial step in the process of bioprosthetic valve failure, and further valve degeneration leading to clinical symptoms is likely to occur in a significant proportion of these cases. This prospective registry will evaluate the clinical outcomes and the valve performance of the SAPIEN 3 Ultra RESILIA valve over 10 years.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Central Contacts