Evaluating the SAPIEN 3 Ultra RESILIA Valve for Aortic Stenosis
Title Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
This study tests how well the new SAPIEN 3 Ultra RESILIA valve works for people with severe aortic stenosis who are getting a heart valve replacement, by checking its performance over the next 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT06420830 on ClinicalTrials.gov |
What this trial studies
This observational registry focuses on patients with severe aortic stenosis who are undergoing transcatheter aortic valve replacement (TAVR) using the SAPIEN 3 Ultra RESILIA valve. The study aims to assess the valve's performance and durability through a series of echocardiographic evaluations conducted at multiple follow-up points over a span of up to 10 years. Key measurements will include transvalvular gradient and other hemodynamic parameters, analyzed by a centralized echocardiographic core lab. The findings will help determine the long-term effectiveness of this latest generation valve in a younger patient population.
Who should consider this trial
Good fit: Ideal candidates are patients with severe aortic stenosis who are eligible for TAVR with the SAPIEN 3 Ultra RESILIA valve.
Not a fit: Patients over 80 years old or those with severe pulmonary or renal dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved valve durability and patient outcomes in those undergoing TAVR for aortic stenosis.
How similar studies have performed: Other studies have shown promising results with similar valve technologies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Québec, Quebec
- Iucpq — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Josep Rodés-Cabau, MD — Iucpq-Ul
- Study coordinator: Josep Rodés-Cabau, MD
- Email: josep.rodes@criucpq.ulaval.ca
- Phone: 4186568711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.