Actively Recruiting

Age: 18Years +
All Genders
NCT07384871

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

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

150

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to develop and validate a fully automated imaging and modeling pipeline for the analysis of mitral valve prolapse (MVP) using real-time three-dimensional transesophageal echocardiography (RT3DE). The primary goal is to automatically segment mitral valve (MV) substructures, extract anatomical landmarks, and generate 3D models of the MV apparatus to characterize morphological and functional features of degenerative MVP. Advanced deep learning techniques and geometric processing tools will be applied to enable automated analysis. A secondary objective is to build patient-specific finite element (FE) models based on RT3DE data to evaluate the biomechanical consequences of MVP and to simulate the effects of surgical repair. These simulations will assess stress distribution and force transmission within the MV apparatus. Additionally, in cases where substantial surgical resection of MV tissue occurs, excised leaflet samples will be collected and preserved for histological and morphometric analysis.

CONDITIONS

Official 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 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

D

Diana Crina Benea

CONTACT

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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