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

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  • Are you between 18 and 80 years old?

Source: NCT06420830, who can take part

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Trial details

Who runs it
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Trial code
NCT06420830
Record updated
4 November 2026
Original description
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-upRead full original descriptionShow less

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

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

Inclusion: Inclusion criteria - Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve; 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.

Exclusion: Severe pulmonary disease (FEV1 <50% predicted or need for home oxygen); Severe coronary disease (SYNTAX score >32); Severe renal dysfunction (eGFR <30 ml/min/1.73m2); Left ventricular ejection fraction ≤30%; Age >80 years; Any disease leading to a life expectancy <5 years; Frailty (Clinical Frailty Scale > 4); Moderate-to-severe mitral regurgitation; Severe tricuspid regurgitation; Pulmonary systolic pressure >60 mmHg; STS-PROM >5%.

ClinicalTrials.gov NCT06420830