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AI-Powered 3D heart scan could revolutionize valve leak diagnosis

NCT ID NCT07528781

Diagnosis Sponsor: Germans Trias i Pujol 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new artificial intelligence software that uses 3D echocardiography to measure mitral regurgitation (a leaky heart valve) more accurately than the standard 2D method. Researchers will compare the 3D tool against cardiac MRI, the current gold standard, in 200 adults with moderate or severe mitral regurgitation. If successful, the tool could help doctors make faster and better treatment decisions, especially during emergency procedures.

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 200 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Apr 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

Patients 18 years old or older with at least moderate mitral regurgitation of any etiology (primary or secondary) who are referred for transesophageal echocardiographic evaluation will be included. During the same day or within 5 days of transesophageal echocardiography, patients with undergo cardiac magnetic resonance. Patients with multiple regurgitant jets will not be excluded. In addition, patients with concomitant mitral stenosis, or other valvular heart disease will not be excluded. Patients with prior mitral valve intervention or bad image quality for analysis of 3D color flow or cardiac magnetic resonance will be excluded. Patients with contraindications for cardiac magnetic resonance will be excluded.

Ages

18 to 95 years

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: * Patients with at least moderate mitral regurgitation of any etiology * Patients with good transesophageal echocardiography image quality Exclusion Criteria: * Patients with prior transcatheter or surgical mitral valve intervention * Patients with contraindications for transesophageal echocardiography or cardiac magnetic resonance

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Conditions

The condition(s) this trial relates to.

follicular lymphoma mitral valve insufficiency

As listed by the trial registrant

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

Moderate or severe mitral regurgitation

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

  • Hospital University Germans Trias i Pujol

    RECRUITING

    Badalona, Barcelona, 08916, Spain