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Heart valve showdown: which measurement method wins for TAVR patients?

NCT ID NCT05459233

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two methods—ultrasound (echocardiography) versus direct pressure measurements (catheterization)—to guide additional balloon inflation after valve-in-valve TAVR. About 310 people with failing surgical aortic valves will be randomly assigned to one method. The goal is to see which approach leads to better valve function, fewer complications, and improved quality of life.

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 valve
What this could lead to
If successful, this could show that using catheter measurements leads to better valve performance and fewer complications after valve-in-valve TAVR.
What could go wrong
This is a mid-sized trial comparing two measurement techniques, not testing a new treatment. The results may not change current practice if the differences are small.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 310 people

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

Started

Jan 2023

Expected to finish

Sep 2029

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Patients with surgical aortic bioprosthetic valve failure defined as severe aortic stenosis and/or regurgitation approved for a valve-in-valve procedure by the Heart Team * Surgical stented bioprosthetic valve (label size ≤25 mm) * TAVR with the SAPIEN 3 Ultra valve Exclusion Criteria: * Stentless or sutureless surgical valves * Trifecta bioprosthesis * Hancock II bioprosthesis * High-risk of coronary obstruction (defined either as a virtual transcatheter valve - coronary distance as evaluated by CT \<4 mm or based on the criterion of the heart team responsible for the procedure). * Impossibility to obtain written informed consent

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Conditions

The condition(s) this trial relates to.

aortic valve insufficiency aortic valve stenosis Prosthesis Failure

As listed by the trial registrant

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

Aortic valve regurgitation Aortic valve stenosis Prosthesis failure

How to take part

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

  1. The places running it

    7 sites in 2 countries. 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

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • South Broward Hospital Disctrict D/B/A Memorial Healthcare System

    RECRUITING

    Hollywood, Florida, 33021, United States

  • St-Joseph's Health INC

    NOT_YET_RECRUITING

    Syracuse, New York, 13203, United States

  • The Christ Hospital Health Network

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of California

    NOT_YET_RECRUITING

    San Francisco, California, 94143, United States

  • William Beaumont Hospital

    RECRUITING

    Royal Oak, Michigan, 48073, United States

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