Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: a Prospective Registry with Central Echocardiography Analysis.

NCT ID: NCT06420830

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-16
• Study Completion Date: 2034-09-01

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.

Conditions

Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

SAPIEN 3 Ultra RESILIA Valve

Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

OTHER

Sponsor Role: lead

Responsible Party

Josep Rodes-Cabau

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josep Rodés-Cabau, MD

Role: PRINCIPAL_INVESTIGATOR

IUCPQ-UL

Emilie Pelletier beaumont, MSc

Role: STUDY_DIRECTOR

Fondation IUCPQ

Locations

IUCPQ

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Josep Rodés-Cabau, MD

Role: CONTACT

josep.rodes@criucpq.ulaval.ca

4186568711

Emilie Pelletier beaumont, MSc

Role: CONTACT

emilie.pelletier-beaumont@criucpq.ulaval.ca

418-656-8711 ext. 3929

Facility Contacts

Josep Rodes-Cabau, MD

Role: primary

josep.rodes@criucpq.ulaval.ca

418-656-8711

Emilie Pelletier Beaumont, MSc

Role: backup

emilie.pelletier-beaumont@criucpq.ulaval.ca

418-656-8711

Josep Rodes-Cabau, MD

Role: backup

References

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Other Identifiers

RESILIA

Identifier Type: -

Identifier Source: org_study_id