Clinical Trial

Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.

Recruiting
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Summary
The issue of valve durability has become one of the most important aspects in the TAVR field in recent years since transcatheter aortic valve replacement has been progressively applied to younger patients with a low co-morbidity burden. The SAPIEN 3 Ultra RESILIA valve represents the last generation of the SAPIEN valve system and includes several important iterations (newer leaflet calcium-blocking technology targeting calcium-attracting free aldehydes, dry tissue storage, newer skirt textile design) that should translate into a favorable impact on valve durability at mid- to long- term follow-up
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-05-15; most recent amendment 2026-03-23.
Status change: Not Yet Recruiting → Recruiting 2025-02-19
Trial Details
NCT Number NCT06420830
Lead Sponsor Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Conditions Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Enrollment 150 participants
Start Date 2024-05-16
Primary Completion 2026-10-01 (estimated)
Study Completion 2034-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-27