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RECRUITING
NCT06420830

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

Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2024-05-16

Completion Date

2034-09-01

Last Updated

2026-03-27

Healthy Volunteers

Not specified

Interventions

PROCEDURE

SAPIEN 3 Ultra RESILIA Valve

Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.

Locations (1)

IUCPQ

Québec, Quebec, Canada