Clinical trial NCT06420830: Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: a Prospective Registry with Central Echocardiography Analysis.
Official title: Title Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: a Prospective Registry with Central Echocardiography Analysis.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Transcatheter Aortic Valve Replacement
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population Patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra RESILIA valve.

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

Detailed description: Prospective observational registry including patients with severe aortic stenosis undergoing TAVR with the SAPIEN 3 Ultra RESILIA valve. All patients who will survive the procedure will undergo a clinical and echocardiographic follow-up at 1-3 months (± 15 days), at 1-year (±30 days), 3-5 year (±30 days), 6-8 year (±30 days) and 9-10 year (±30 days) after valve implantation. Transthoracic echocardiography (TTE) exams (baseline, 1-3-month, 1 year, 3-5 years, 6-8 years, and 9-10 years post-procedure) will be evaluated in a Centralized Echocardiographic Core Lab at the Quebec Heart and Lung Institute. The measurements obtained in the Core Lab regarding transvalvular gradient, EOA, PPM and PVL at 1-3 months will determine the primary outcome of the study.

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

Primary outcomes:
measure: Transvalvular gradient
timeFrame: 1-3 months
measure: Effective orifice area (EOA)
timeFrame: 1-3 months
measure: Prosthesis-patient mismatch
timeFrame: 1-3 months
measure: Paravalvular leaks
timeFrame: 1-3 months
Secondary outcomes:
measure: Transvalvular gradient
timeFrame: 1-, 3-5-, 6-8-, and 9-10-year follow-up.
measure: Effective orifice area (EOA)
timeFrame: 1-, 3-5-, 6-8-, and 9-10-year follow-up.
measure: Bioprosthetic valve dysfunction
timeFrame: 1-, 3-5-, 6-8-, and 9-10-year follow-up.
measure: Paravalvular leaks
timeFrame: 1-, 3-5-, 6-8-, and 9-10-year follow-up.
measure: Bioprosthetic valve dysfunction
timeFrame: yearly
measure: Bioprosthetic valve failure
timeFrame: yearly
measure: Bioprosthetic valve failure
timeFrame: 1-, 3-5-, 6-8-, and 9-10-year follow-up.
measure: Clinical events
timeFrame: 1month and yearly up to 10-year
measure: Valve thrombosis
timeFrame: 1-3 months and yearly up to 10-year
measure: Valve endocarditis
timeFrame: 1-3 months and yearly up to 10-year
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: IUCPQ
Study officials:
affiliation: IUCPQ-UL
name: Josep Rodés-Cabau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondation IUCPQ
name: Emilie Pelletier beaumont, MSc
role: STUDY_DIRECTOR
References:
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