Actively Recruiting

Age: 18Years +
All Genders
ID07384871

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

Led by IRCCS Policlinico S. Donato · Updated on 2026-02-03

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to develop and validate an automated imaging and modeling system to analyze mitral valve prolapse (MVP) using real-time three-dimensional transesophageal echocardiography (RT3DE). The study focuses on automatically segmenting the mitral valve substructures, extracting key anatomical landmarks, and creating 3D models to assess the shape and function of degenerative MVP. Advanced deep learning and geometric tools will be used to improve analysis. Additionally, patient-specific biomechanical models will be built to study the effects of MVP and surgical repairs on the valve's structure and forces. Imaging will be performed during surgery using a specialized ultrasound system in standard views of the mitral valve and left ventricle. Surgical repair techniques include leaflet tissue removal, artificial chordae implantation, and annuloplasty for valve stabilization. When significant valve tissue is removed, samples will be collected and preserved for detailed tissue analysis. The study also involves training a neural network on segmented images to enable automated processing and 3D model generation. Participants will undergo intraoperative imaging as part of their MVP surgery, with clinical data collected anonymously. The automated system will be tested for its accuracy in segmenting valve structures and extracting features over 36 months. Biomechanical simulations will evaluate changes after surgery. No extra follow-up is needed beyond standard care. The study focuses on image analysis and modeling performed after surgery, lasting up to the completion date in 2028.

CONDITIONS

Brief Title

AI-Based Shape and Function Analysis of Mitral Valve Prolapse Using 3D Ultrasound

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients (age > 18 years old)
  • Documented symptomatic degenerative mitral valve regurgitation with indication for surgical repair
  • Undergoing periprocedural transesophageal 3D echocardiography of the mitral valve apparatus
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Inadequate quality of 3D transesophageal echocardiography imaging
  • Imaging with temporal resolution below 20 Hz
  • Previous treatment with prosthetic mitral valve replacement

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Day of surgery

Participants undergo intraoperative real-time 3D echocardiography (RT3DE) imaging of the mitral valve during surgical mitral valve prolapse repair as part of standard clinical care.

1 visit (in-person, intraoperative imaging)

Surgery and Immediate Post-operative Care

Duration - Surgical procedure day

Participants undergo mitral valve prolapse surgical repair involving leaflet resection, neochordal implantation, and annuloplasty. Tissue samples may be collected during surgery for histological analysis.

1 visit (in-person, surgery)

Post-operative Follow-up

Duration - Up to 2 weeks after surgery

Participants receive standard clinical follow-up after surgery. No additional study-specific follow-up visits are required.

Trial Site Locations

Total: 1 location

1

IRCCS Policlinico San Donato

San Donato Milanese, Italy, 20097

Actively Recruiting

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Research Team

F

Francesco Sturla

D

Diana Crina Benea

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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