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Large study aims to clarify risks for patients with mixed aortic valve disease

NCT ID NCT06789211

Knowledge-focused Sponsor: Leiden University Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This observational study will follow 1900 people with moderate mixed aortic valve disease (a combination of aortic stenosis and regurgitation) to see how symptoms and heart function relate to survival and the need for valve replacement. Researchers hope to identify which patients are at higher risk and might benefit from earlier intervention. Currently, there are no clear guidelines for treating this condition, so the study aims to fill that knowledge gap.

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 study could help doctors identify which patients with moderate mixed aortic valve disease might benefit from early valve intervention, potentially improving survival and quality of life.
What could go wrong
This is an observational study, not a treatment trial, so it will not directly test any new therapy. The results may only confirm current uncertainty and not lead to immediate changes in care.

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 1,900 people

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

Started

Jun 2024

Expected to finish

Dec 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 with concomitant moderate AS and moderate AR, patients with isolated severe AS and isolated severe AR.

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: 1. Patients with concomitant moderate AS and moderate AR 2. Patients with isolated severe AS 3. Patients with isolated severe AR Exclusion Criteria: 1. Previous aortic valve surgery 2. Concomitant left valvular heart disease more than mild grade 3. Acute AR 4. Bad echocardiographic image quality

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Conditions

The condition(s) this trial relates to.

aortic valve disorder aortic valve insufficiency aortic valve stenosis heart valve disorder

As listed by the trial registrant

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

Mixed aortic valve disease

How to take part

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

  1. The places running it

    1 site. 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

  • Leiden University Medical Center

    RECRUITING

    Leiden, South Holland, 2333ZA, Netherlands