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Heart valve unit may cut brain fog after procedure, study hopes

NCT ID NCT07626567

Knowledge-focused Sponsor: Heart and Brain Research Group, Germany 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This study will follow 500 people with severe aortic stenosis who need a heart valve replacement. Researchers want to see if a dedicated Heart Valve Unit—a team of heart specialists working together—can reduce confusion, delirium, and memory problems that sometimes happen after the procedure. Participants will take thinking and memory tests before the procedure, at hospital discharge, and three months later.

What this could mean

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

What this could lead to
If successful, this could show that organizing heart valve care in a specialized unit helps prevent short-term memory and thinking problems after the procedure.
What could go wrong
This is an observational study, not a treatment trial. It will only measure outcomes, not test a new drug or device. Results may not apply to all hospitals or 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.

Participants

About 500 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

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

Consecutive adult patients undergoing transcatheter valve therapy at the Kerckhoff-Klinik Bad Nauheim, Germany, who meet study eligibility criteria and are treated during predefined observation periods before, during, and after Heart Valve Unit implementation.

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 aortic valve stenosis * Indication for transcatheter valve therapy according to current guideline recommendations and/or Heart-Team consensus * Sufficient German language proficiency, as study-related tests, questionnaires, and instructions are administered in German * Age ≥18 years * Willingness to participate voluntarily with written informed consent Exclusion Criteria: * Known pregnancy at the time of study inclusion * Life expectancy \<1 year due to non-cardiac disease * Pre-interventional psychiatric and neurological disorders (known and diagnosed dementia, depression, history of stroke or transient ischemic attack \[TIA\], migraine, epilepsy) with acute symptoms that may interfere with data collection

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis cognitive disorder delirium Emergence Delirium Postoperative Cognitive Complications

As listed by the trial registrant

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

Aortic valve stenosis Delirium, postoperative Neurocognitive disorders Postoperative cognitive dysfunction (POCD)

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.