Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: a Prospective Registry with Central Echocardiography Analysis.

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

Status: Enrolling

Conditions: Transcatheter Aortic Valve Replacement; Aortic Valve Stenosis

Treatments: Procedure: SAPIEN 3 Ultra RESILIA Valve

Study type: Observational

Funder types: Other

Identifiers

NCT06420830

RESILIA

Details and patient eligibility

About

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

Full description

Prospective observational registry including patients with severe aortic stenosis undergoing TAVR with the SAPIEN 3 Ultra RESILIA valve. All patients who will survive the procedure will undergo a clinical and echocardiographic follow-up at 1-3 months (± 15 days), at 1-year (±30 days), 3-5 year (±30 days), 6-8 year (±30 days) and 9-10 year (±30 days) after valve implantation. Transthoracic echocardiography (TTE) exams (baseline, 1-3-month, 1 year, 3-5 years, 6-8 years, and 9-10 years post-procedure) will be evaluated in a Centralized Echocardiographic Core Lab at the Quebec Heart and Lung Institute. The measurements obtained in the Core Lab regarding transvalvular gradient, EOA, PPM and PVL at 1-3 months will determine the primary outcome of the study.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

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