SAPIEN 3 Ultra RESILIA Valve: Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.
Study 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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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
Effective orifice area (EOA) — 1-3 months EOA evaluated by echocardiography imaging
Prosthesis-patient mismatch — 1-3 months Moderate or severe prothesis-patient mismatch (defines as an index aortic valve area 0.85-0.66 cm2/m2 (moderate), ≤0.65 cm2/m2 (severe) for patient with BMI ˂30km/m2 and 0.70-0.56 cm2/m2 (moderate), ≤0.55 cm2/m2 (severe) for patient with BMI ≥30km/m2 and/or moderate-severe aortic regurgitation (AR) (VARC-3 definition).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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