Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
NCT06420830 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150
Last updated 2026-03-27
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
Conditions
- Aortic Valve Stenosis
- Transcatheter Aortic Valve Replacement
Interventions
- PROCEDURE
-
SAPIEN 3 Ultra RESILIA Valve
Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.
Sponsors & Collaborators
-
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
lead OTHER
Principal Investigators
-
Josep Rodés-Cabau, MD · IUCPQ-UL
-
Emilie Pelletier beaumont, MSc · Fondation IUCPQ
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-16
- Primary Completion
- 2026-10-01
- Completion
- 2034-09-01
Countries
- Canada
Study Locations
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