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New heart valve aims for better Long-Term results

NCT ID NCT06420830

Disease control Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is tracking 150 people who receive a new type of heart valve (SAPIEN 3 Ultra RESILIA) to see how well it works over time. The valve has special features to prevent calcium buildup and improve durability. Researchers will use echocardiograms to measure valve function and check for leaks or other problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAPIEN 3 Ultra RESILIA valve (a replacement heart valve)
What this could lead to
If successful, this could show that the new valve lasts longer and works better than older versions, improving long-term outcomes for people with severe aortic stenosis.
What could go wrong
This is an observational registry, not a randomized trial, so results may not prove the valve is better. Valve durability can only be assessed over many years, and this study may not be long enough to see clear differences.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Sep 2034

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Population Patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra RESILIA valve.

Ages

18 to 80 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic valve stenosis Transcatheter aortic valve replacement

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IUCPQ

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

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