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Heart valve mystery: why do some TAVI replacements fail faster?

NCT ID NCT05758662

Knowledge-focused Sponsor: St. Antonius Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at why some replacement heart valves (TAVI) may wear out faster than others. Researchers will use special PET-CT scans to detect early signs of valve damage in 180 people who had TAVI about five years ago. They want to see if small blood clots on the valve or the type of valve used affect how long the valve lasts.

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 180 people

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

Started

Nov 2023

Expected to finish

Oct 2026

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

Patients who underwent TAVI about five years ago will be consecutively screened for eligibility from the ongoing, prospective, TAVI registries of the participating study sites and will be asked to undergo hybrid PET-CT imaging and transthoracic echocardiography.

Ages

18 years and older

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: * Successful TAVI with Sapien or CoreValve Evolut prosthesis about 5 years ago * Able to undergo hybrid 18F-NaF PET-CT imaging and transthoracic echocardiography * Written informed consent Exclusion Criteria: * Temporary or chronic oral anticoagulation use after TAVI * Known severe renal insufficiency * Known severe paravalvular regurgitation * History of valve-in-valve procedure * History of aortic valve re-intervention (including percutaneous paravalvular leak closure)

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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

How to take part

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

  1. The places running it

    4 sites in 3 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

  • Amsterdam UMC

    RECRUITING

    Amsterdam, Netherlands

  • Rigshospitalet

    RECRUITING

    Copenhagen, Denmark

  • St. Antonius Hospital

    RECRUITING

    Nieuwegein, Utrecht, 3435 CM, Netherlands

  • University of Edinburgh

    NOT_YET_RECRUITING

    Edinburgh, United Kingdom

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