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AI could revolutionize heart valve surgery predictions

NCT ID NCT07213531

Knowledge-focused Sponsor: Montreal Heart Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 uses artificial intelligence to analyze data from 21,000 patients who had heart valve procedures. The goal is to make AI tools that can predict surgery outcomes, like which device to use and risks of complications, with over 90% accuracy. This is a non-interventional study, meaning no new treatments are tested—just data analysis to improve future 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 21,000 people

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

Started

May 2024

Expected to finish

May 2029

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 heart valve disease eligible for transcatheter interventions (TAVI, M-TEER, TMVI, TTVI).

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: Patients who have reached the age of legal majority under local laws. * For TAVI group: All patients who have had TAVI with a third generation transcatheter heart valve (THV), with an available pre-procedural optimal quality CT scan as defined by an ECG- gating CT with: 1. five to ten image volumes at cardiac phases from 5% to 95% R-R 2. 0.625 mm slice thickness 3. 0.625 mm spacing between slices 4. 0.88 mm in-plane pixel spacing * For TMVI group: Patients who have had a TMVI with a dedicated device and screen failures, with an available optimal quality CT scan. * For TTVI group: Patients who have had a TTVI with a dedicated device and screen failures, with an available optimal quality CT scan. * For M-TEER: All patient who have had a M-TEER with 1) G4 or newer iteration of MitraClip or 2) G2 or newer iteration of Pascal, with available pre-procedural TEE videos images from one of two vendors: Phillips or GE, with clear identifiable views of the Mitral valve, frame per second equal or higher than 40 frames per second, acceptable 3D reconstructions. * For T-TEER: All patient who have had a T-TEER with G4 or newer iteration of TriClip or 2) G2 or newer iteration of Pascal, with available pre-procedural TEE videos images from one of two vendors: Phillips or GE, with clear identifiable views of the Tricuspid valve, frame per second equal or higher than 40 frames per second, acceptable transgastric image with acceptable 3D reconstructions. Exclusion Criteria: * For TAVI group: Valve-in-valve procedures * For TMVI group: Valve-in-valve and valve-in-ring procedures * For TTVI: Valve-in-valve and valve-in-ring procedures * For M-TEER: G3 or older MitraClip, G1 Pascal * For T-TEER: G3 Triclip, G1 Pascal

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Conditions

The condition(s) this trial relates to.

aortic valve disorder aortic valve stenosis heart valve disorder mitral valve disorder mitral valve insufficiency tricuspid valve disorder tricuspid valve insufficiency twin to twin transfusion syndrome

As listed by the trial registrant

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

Heart valve disease M-teer Mitraclip T-teer TAVI TMVI Triclip TTVI

How to take part

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

  1. The places running it

    15 sites in 5 countries. 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

  • CHU Lille

    RECRUITING

    Lille, France

  • CHU Marseille

    RECRUITING

    Marseille, France

  • Centre Cardiologique du Nord Paris

    RECRUITING

    Paris, France

  • Centre Hospitalier Universitaire (CHU) de Bordeaux, 12 rue Dubernat 33404 Talence cedex

    RECRUITING

    Bourdeaux, 33404, France

  • Centre Hospitalier Universitaire Rennes

    RECRUITING

    Rennes, France

  • Clinque Pasteur Toulouse - France

    RECRUITING

    Toulouse, France

  • Heart Valve Center Mainz

    RECRUITING

    Mainz, Germany

  • Institut Cardiovasculaire Paris-Sud Paris

    RECRUITING

    Paris, France

  • Istituto Clinico Città di Brescia

    RECRUITING

    Brescia, Italy

  • Montefiore Medical Center New York

    RECRUITING

    New York, New York, 10467, United States

  • Montreal Heart Institute, 5000 Rue Bélanger, Montréal

    RECRUITING

    Montreal, Quebec, H1T 1C8, Canada

  • San Raffaele Heart Valve Center Milan

    RECRUITING

    Milan, Italy

  • St Michael's Hospital Toronto

    RECRUITING

    Toronto, Canada

  • St Paul's Hospital Vancouver

    RECRUITING

    Vancouver, Canada

  • University Medical Center Hamburg-Eppendorf

    RECRUITING

    Hamburg, Germany

More trials for these conditions

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