Evaluating the SAPIEN 3 Ultra RESILIA Valve for Aortic Stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.