Recruiting

SAPIEN 3 Ultra

Sponsor:

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

Code:

NCT06420830

Conditions

Aortic Valve Stenosis

Transcatheter Aortic Valve Replacement

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SAPIEN 3 Ultra RESILIA Valve

Study Details

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

Conditions

Aortic Valve Stenosis

Transcatheter Aortic Valve Replacement

Study ID

NCT06420830

Start date

May 16, 2024

Status verified date

Mar, 2026

Completion date

Sep 1, 2034

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Interventions

SAPIEN 3 Ultra RESILIA Valve

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

Primary outcome measure

  • Transvalvular gradient [ Time Frame: 1-3 months ]
  • Effective orifice area (EOA) [ Time Frame: 1-3 months ]
  • Prosthesis-patient mismatch [ Time Frame: 1-3 months ]
  • Paravalvular leaks [ Time Frame: 1-3 months ]

Central Contacts and Locations

Central contacts

Josep Rodés-Cabau, MD

4186568711josep.rodes@criucpq.ulaval.ca

Emilie Pelletier beaumont, MSc

418-656-8711emilie.pelletier-beaumont@criucpq.ulaval.ca

Locations

IUCPQ

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Josep Rodes-Cabau, MD

418-656-8711josep.rodes@criucpq.ulaval.ca

Emilie Pelletier Beaumont, MSc

418-656-8711emilie.pelletier-beaumont@criucpq.ulaval.ca

Principal Investigator:

Josep Rodes-Cabau, MD

More Information

Sponsor

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

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval on 2026-03-27.