Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT06420830

Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.

Led by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Updated on 2026-03-27

150

Participants Needed

1

Research Sites

537 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with severe aortic stenosis undergoing transarterial TAVR with the SAPIEN 3 Ultra RESILIA valve.
  • Successful implantation of the SAPIEN 3 Ultra RESILIA valve.
  • Freedom from mortality during the procedure.
  • Successful access, delivery, and retrieval of the device.
  • Correct positioning of a single prosthetic heart valve in the proper anatomical location.
  • No need for surgery or intervention related to the device (except permanent pacemaker) or major vascular or cardiac structural complications.
  • Absence of severe procedural or in-hospital complications including mortality, stroke, significant bleeding, myocardial infarction, need for a second valve, valve embolization, coronary obstruction, or annular rupture according to VARC-3 definitions.
Not Eligible

You will not qualify if you...

  • Age greater than 80 years.
  • Severe pulmonary disease with FEV1 less than 50% predicted or need for home oxygen.
  • Severe renal dysfunction with eGFR less than 30 ml/min/1.73m2.
  • Frailty with a Clinical Frailty Scale score greater than 4.
  • Severe coronary disease with SYNTAX score greater than 32.
  • Left ventricular ejection fraction 30% or less.
  • Moderate-to-severe mitral regurgitation.
  • Severe tricuspid regurgitation.
  • Pulmonary systolic pressure greater than 60 mmHg.
  • STS-PROM score greater than 5%.
  • Any disease causing life expectancy less than 5 years.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

IUCPQ

Québec, Quebec, Canada, G1V 4G5

Actively Recruiting

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Research Team

J

Josep Rodés-Cabau, MD

CONTACT

E

Emilie Pelletier beaumont, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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