RecruitingNCT06420830

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

Title 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

Enrollment

150 participants

Start Date

May 16, 2024

Study Type

OBSERVATIONAL

Conditions

Aortic Valve Stenosis Transcatheter Aortic Valve Replacement

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

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

Successful valve implantation of the SAPIEN 3 Ultra RESILIA valve.
VARC-3- defined technical success defined as:
Freedom from mortality
Successful access, delivery of the device, and retrieval of the delivery system
Correct positioning of a single prosthetic heart valve into the proper anatomical location
Freedom from surgery or intervention related to the device (excluding permanent pacemaker) or to a major vascular or access related, or cardiac structural complication - Absence of severe procedural or in-hospital complications (VARC-3 definitions): mortality, stroke, bleeding type 2-4, myocardial infarction, need for a second valve, valve embolization, coronary obstruction, annular rupture.