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Artificial intelligence could make heart valve surgery safer and more precise

NCT ID NCT07632794

Knowledge-focused Sponsor: Mi Chen 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether artificial intelligence can help doctors see heart valve structures more clearly during a minimally invasive repair procedure called TEER. Researchers will use data from 1,500 patients who have already had the procedure to train and test the AI. The goal is to automate the recognition of valve parts and clip components, potentially making the procedure faster and more accurate.

What this could mean

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

Active substance
Artificial intelligence software
What this could lead to
If successful, this AI tool could help doctors perform mitral valve repairs more accurately and consistently, potentially improving patient outcomes.
What could go wrong
This is a retrospective study using existing data, not a prospective trial. The AI may not perform as well in real-time or in all patients, and it does not directly test a new treatment.

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 1,500 people

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

Started

Sep 2025

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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 population consists of adult patients with degenerative or functional mitral regurgitation who underwent Transcatheter Mitral Edge-to-Edge Repair (TEER) with the MitraClip device at multiple participating high-volume structural heart centers. All data are derived from routine clinical care, including intraprocedural transesophageal echocardiographic (TEE) imaging and corresponding clinical records. Only patients with appropriate consent for research use of their data, as defined by the policy of each participating center, are included. The cohort reflects real-world TEER practice across diverse imaging environments, operator experience, and patient anatomies, supporting the development and validation of artificial intelligence-based segmentation and measurement tools with improved generalizability.

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 (≥18 years of age) at the time of the index procedure * Confirmed diagnosis of degenerative or functional mitral regurgitation * Underwent Transcatheter Mitral Edge-to-Edge Repair (TEER) with the MitraClip device at one of the participating centers * Intraprocedural transesophageal echocardiographic (TEE) imaging available, complete, and of sufficient quality to support semantic segmentation and real-time measurement analyses * Appropriate consent for research use of clinical and imaging data, as per the policy of each participating center Exclusion Criteria: * Incomplete or poor-quality intraprocedural TEE imaging unsuitable for accurate segmentation and measurement * Ambiguous or unconfirmed diagnosis of mitral regurgitation * Documented refusal to allow use of clinical or imaging data for research purposes * Missing essential clinical documentation required to confirm eligibility

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Conditions

The condition(s) this trial relates to.

mitral valve insufficiency

As listed by the trial registrant

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

Mitral regurgitation

Contacts and locations

Locations

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100037, China

  • IRCCS Policlinico San Donato

    Milan, Italy

  • San Raffaele Hospital

    Milan, Italy

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