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

NCT07384871 | Recruiting

• 1 other identifier: AI4MVP
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Mitral Valve Prolapse; Myxomatous Mitral Valve Degeneration

Outcome Measures

Primary Outcomes (1)

• Accuracy of automated MV substructure segmentation and extraction of anatomical landmarks from RT3DE

  The accuracy of AI-based automated segmentation of MV substructures (anterior and posterior leaflets, mitral annulus, and papillary muscles) from RT3DE is assessed using expert manual segmentation as reference standard and analyzing the following measures: i) Dice Similarity Coefficient (DSC, -); ii) Mean Surface Distance (MSD, mm); iii) Hausdorff Distance (HD, mm). Accuracy of AI-based automated identification of key MV anatomical landmarks relevant to degenerative mitral valve prolapse is assessed compared with expert manual annotation analyzing the Euclidean distance error (mm) between automated and expert-defined landmarks (annular hinge points, leaflet free-edge points, coaptation line, papillary muscle tips).

  36 months

Secondary Outcomes (8)

• Automated quantification of MV morphometric and functional descriptors

  36 months

• Change in mechanical stress of MV leaflets following surgical MVP repair

  Up to 1 month after MVP surgical repair

• Change in mechanical load transfer to MV sub-apparatus following surgical MVP repair

  Up to 1 month after MVP surgical repair

• Change in mechanical stress of MV papillary muscles following surgical MVP repair

  Up to 1 month after MVP surgical repair

• Change in coaptation of MV leaflets following surgical MV repair

  Up to 1 month after MVP surgical repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will focus on patients referred to IRCCS Policlinico San Donato for surgical MVP repair. The study will exploit the standard clinical imaging required during MVP surgical repair and will have no impact on the clinical procedure. No variation in prophylaxis or follow-up is expected compared to those of practice as suggested by the international guideline. Hence, there are no physical, psychological, and social risks and/or direct benefits associated with the activities carried out during the study.

You may qualify if:

• 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.

You may not qualify if:

• Inadequate quality of 3DRTE imaging, e.g., due to inadequate patient-specific acoustic window;
• DRTE imaging with a temporal resolution of \< 20 Hz;
• Patient treated through prosthetic MV replacement.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, 20097, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

In case of surgically excised MV tissue due to substantial (i.e., at least 10×10 mm) leaflet resection, samples of leaflets' tissue will be harvested and therefore stored in the institutional BioCor biobank for subsequent histomorphometric analysis. Collected samples will undergo quantitative analysis of tissue thickness and ad hoc structural stains of leaflet morphological features. Biological samples will be finally destroyed after the evaluations.

MeSH Terms

Conditions

Mitral Valve Prolapse

Condition Hierarchy (Ancestors)

Heart Valve Prolapse; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Francesco Sturla

CONTACT

+390252774353; francesco.sturla@grupposandonato.it

Diana Crina Benea

CONTACT

+390252774765; dianacrina.benea@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 3, 2026
• Study Start: May 26, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

IT (1)