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New TAVI technique aims to stop silent valve clots

NCT ID NCT07042529

Disease control Sponsor: Ole De Backer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 1 time

Summary

This study tests whether a special method to expand a new heart valve during TAVI can reduce harmful thickening of the valve leaflets. About 620 people with severe aortic stenosis who do not have atrial fibrillation will be randomly assigned to either the optimized expansion method or standard care. The main goal is to see if the new approach leads to less leaflet thickening on a CT scan three months after the procedure.

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 1,010 people

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

Started

Oct 2025

Expected to finish

Jul 2033

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: * Severe native aortic valve stenosis * Indication for TAVI * Ability to understand and to comply with the study protocol Exclusion Criteria: * Existing indication for oral anticoagulation (e.g., atrial fibrillation, venous thromboembolism, antiphospholipid syndrome, mechanical mitral valve) * Creatinine clearance \<15 mL/min (CKD-EPI formula) or on renal replacement therapy * Iodine contrast allergy or other condition that prohibits cardiac CT imaging

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis heart valve disorder

As listed by the trial registrant

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

Aortic stenosis disease Valvular heart disease

How to take part

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

  1. The places running it

    17 sites in 6 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

  • AZ Delta

    RECRUITING

    Roeselare, Belgium

  • AZORG ziekenhuis

    RECRUITING

    Aalst, Belgium

  • Aalborg University Hospital

    RECRUITING

    Aalborg, 9000, Denmark

  • CHU Charleroi

    RECRUITING

    Charleroi, 6000, Belgium

  • Haukeland hospital

    RECRUITING

    Haukeland, Norway

  • Leiden University Medical Center

    RECRUITING

    Leiden, Netherlands

  • Odense University Hospital

    NOT_YET_RECRUITING

    Odense C, 5000, Denmark

  • Oslo universitetssygehus

    RECRUITING

    Oslo, 0450, Norway

  • Rigshospitalet

    RECRUITING

    Copenhagen, Denmark

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, 413 45, Sweden

  • Skejby Hospital

    NOT_YET_RECRUITING

    Aa, 8200, Denmark

  • Skånes universitetssjukhus

    RECRUITING

    Skåne, Sweden

  • St. Antonius Hospital

    RECRUITING

    Nieuwegein, 3435, Netherlands

  • Turku University Hospital

    RECRUITING

    Turku, 20520, Finland

  • UMC Amsterdam

    RECRUITING

    Amsterdam, Netherlands

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University Medical Center Groningen

    RECRUITING

    Groningen, Netherlands

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