Clinical trial Recruiting at 1 site Observational Ages 18 and up

AI and 3D ultrasound mapping of mitral valve prolapse shape and function.

Official title: AI-Based Morphological Analysis and Biomechanical Numerical Evaluation of Mitral Valve Prolapse (MVP) From Real-Time 3D Echocardiography (RT3DE)

Run by IRCCS Policlinico S. Donato · NCT07384871 · Data updated 2026-11-12

This project tests an automated AI system that uses intraoperative 3D transesophageal ultrasound to map mitral valve anatomy and create patient-specific biomechanical models for adults having surgery for degenerative mitral valve prolapse.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment150 (estimated)
SponsorIRCCS Policlinico S. Donato
Academic / other
Locations1 site (San Donato Milanese)
StatusRecruiting
StartedMay 26, 2025
Main results expectedMay 2028
Study endsMay 2028
Registry record updatedFebruary 3, 2026
Trial IDNCT07384871 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults (age >18) with symptomatic degenerative mitral regurgitation scheduled for mitral valve repair who can undergo intraoperative RT3DE and provide informed consent.

Probably not a fit

Patients with poor-quality 3D transesophageal images (including temporal resolution <20 Hz), those undergoing valve replacement, or those not having intraoperative RT3DE are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects intraoperative real-time 3D transesophageal echocardiography (RT3DE) during mitral valve repair to build an imaging dataset. Advanced deep learning algorithms will automatically segment valve substructures, extract anatomical landmarks, and generate high-resolution 3D valve models. Patient-specific finite element models will be created from the 3D data to simulate stresses, force transmission, and the biomechanical effects of different surgical repairs. When available, excised leaflet tissue will be preserved for histology, and all imaging datasets will be anonymized prior to analysis.

Why it matters

Potential benefit: If successful, this could give surgeons personalized 3D maps and simulations to improve repair planning and reduce unexpected outcomes.

How similar studies have gone: Previous work has shown promising results for AI-based valve segmentation and 3D echo analysis, but fully automated pipelines combined with patient-specific finite element surgical simulations remain relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • IRCCS Policlinico San Donato
    San Donato Milanese, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.