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AI reads heart scans to help surgeons fix leaky valves

NCT ID NCT07384871

Knowledge-focused Sponsor: IRCCS Policlinico S. Donato 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study is developing an artificial intelligence (AI) system to automatically analyze 3D ultrasound images of the heart in people with mitral valve prolapse, a condition where a heart valve doesn't close properly. The AI will measure the valve's shape and movement, and create computer models to simulate surgical repair. Researchers aim to improve how surgeons plan and perform these operations. The study involves 150 adults scheduled for mitral valve surgery.

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 lead to better surgical planning and outcomes for people with mitral valve prolapse by providing detailed, automated analysis of heart valve structure and function.
What could go wrong
This is an early-stage observational study focused on developing and testing a new analysis method, not a treatment. The AI tool may not work well in all patients or may not improve surgical results.

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 150 people

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

Started

May 2025

Expected to finish

May 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

The study will focus on patients referred to IRCCS Policlinico San Donato for surgical MVP repair. The study will exploit the standard clinical imaging required during MVP surgical repair and will have no impact on the clinical procedure. No variation in prophylaxis or follow-up is expected compared to those of practice as suggested by the international guideline. Hence, there are no physical, psychological, and social risks and/or direct benefits associated with the activities carried out during the study.

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: * Adult patients (age \> 18 years old); * Documented symptomatic degenerative MR with indication to MVP surgical repair, following the Heart Team decision; * Periprocedural transesophageal 3DRTE of the MV apparatus, which is clinical standard modality for morphological assessment and guidance during MVP surgical repair; * Signed informed consent. Exclusion Criteria: * Inadequate quality of 3DRTE imaging, e.g., due to inadequate patient-specific acoustic window; * 3DRTE imaging with a temporal resolution of \< 20 Hz; * Patient treated through prosthetic MV replacement.

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Conditions

The condition(s) this trial relates to.

mitral valve prolapse

As listed by the trial registrant

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

Mitral valve prolapse Myxomatous mitral valve degeneration

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

  • IRCCS Policlinico San Donato

    RECRUITING

    San Donato Milanese, 20097, Italy

More trials for these conditions

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