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

Launched by INSTITUT UNIVERSITAIRE DE CARDIOLOGIE ET DE PNEUMOLOGIE DE QUÉBEC, UNIVERSITY LAVAL · May 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of heart valve called the SAPIEN 3 Ultra RESILIA valve, which is used for patients with a condition known as aortic stenosis. Aortic stenosis occurs when the heart's aortic valve narrows, making it difficult for blood to flow. The trial aims to see how well this valve works over time, especially since more younger patients are receiving this treatment. Researchers believe that the new design of this valve may help it last longer and perform better compared to older versions.

To take part in this study, participants need to be between the ages of 65 and 74 and have severe aortic stenosis. They must be undergoing a procedure known as transcatheter aortic valve replacement (TAVR) and have a successful valve implantation. However, individuals over 80 years old or those with certain health issues, like severe lung or kidney problems, may not be eligible. Participants can expect careful monitoring of their health and the valve's performance, helping doctors learn more about this new valve and how it can benefit future patients.

Gender

ALL

Eligibility criteria

• 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