NCT06420830 Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
| NCT ID | NCT06420830 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval |
| Condition | Aortic Valve Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-05-16 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2024-05-16 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Josep Rodés-Cabau, MD
PRINCIPAL INVESTIGATOR
IUCPQ-UL
Frequently Asked Questions
Who can join the NCT06420830 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06420830 currently recruiting?
Yes, NCT06420830 is actively recruiting participants. Contact the research team at josep.rodes@criucpq.ulaval.ca for enrollment information.
Where is the NCT06420830 trial being conducted?
This trial is being conducted at Québec, Canada.
Who is sponsoring the NCT06420830 clinical trial?
NCT06420830 is sponsored by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval. The principal investigator is Josep Rodés-Cabau, MD at IUCPQ-UL. The trial plans to enroll 150 participants.