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Heart valve showdown: which TAVI valve sends fewer particles to the brain?

NCT ID NCT07614100

Knowledge-focused Sponsor: Ivan Zeljkovic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will compare two common types of heart valves used in TAVI (a procedure to replace a narrowed aortic valve) to see which one sends fewer tiny particles to the brain during the procedure. 80 adults with severe aortic stenosis will be randomly assigned to receive either a balloon-expandable or a self-expanding valve. Researchers will use ultrasound to monitor brain particles before, during, and after the procedure to understand how valve choice affects stroke risk.

What this could mean

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

Active substance
Balloon-expandable or self-expanding transcatheter aortic valve
What this could lead to
If it works, this could help doctors choose the valve type that reduces tiny brain particles during TAVI, possibly lowering stroke risk.
What could go wrong
This is a small, early-stage study that only measures microemboli, not actual strokes. The results may not change practice or apply to all patients.

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 80 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

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: * Age 18 years or older * Severe symptomatic aortic valve stenosis * Clinical indication for transcatheter aortic valve implantation * Feasibility of transcranial Doppler ultrasound monitoring * Signed written informed consent Exclusion Criteria: * Recent stroke or transient ischemic attack * Significant cerebrovascular disease preventing reliable transcranial Doppler -assessment * Previous aortic valve implantation * Active endocarditis * Pregnancy or breastfeeding

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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 stenosis

How to take part

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

  1. The places running it

    2 sites. 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

  • Sisters of Charity Hospital Zagreb

    Zagreb, 10000, Croatia

  • UH Dubrava

    Zagreb, 10000, Croatia

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