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Mitral Valve ProlapseAI4MVPNCT07384871

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

An observational study of Mitral Valve Prolapse and Myxomatous Mitral Valve Degeneration, run by IRCCS Policlinico S. Donato at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
How many people
150 participants
Where
1 siteItaly
Study dates
26 May 2025to May 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site, 1 recruiting
  • IRCCS Policlinico San Donato

    San Donato Milanese, 20097

    Francesco Sturla, +390252774353, francesco.sturla@grupposandonato.it

    Diana Benea, +390252774765, dianacrina.benea@grupposandonato.it

    Recruiting

Other trials in Italy

About this study

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

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.

Read the detailed description

This prospective study aims to investigate the anatomical and biomechanical characteristics of MVP using RT3DEE and advanced artificial intelligence (AI)-based image analysis techniques. The goal is to develop an automated framework for the segmentation and morphological assessment of the MV apparatus, and to conduct FE modeling to evaluate the biomechanical implications of degenerative MVP and associated surgical repairs.

Imaging Protocol Intraoperative RT3DE will be performed in the operating room as part of the standard imaging protocol during surgical MVP repair. A Vivid S70N ultrasound system (GE Healthcare) equipped with a 6VT 4D multiplane RT3DE probe will be used. Standard mid-esophageal RT3DE views will be acquired, including full left ventricular (LV) chamber volumes and zoomed, gated 3D views of the MV complex (annulus, leaflets, and papillary muscles). To enhance image quality, zoomed acquisitions will be limited to the smallest pyramidal volume capturing the entire mitral complex, ensuring frame rates ≥20 Hz. All imaging datasets will be anonymized prior to analysis.

Surgical Protocol MVP surgical repair will be conducted under general anesthesia through a right mini-thoracotomy. Surgical techniques will include: i) leaflet resection (removal of excess leaflet tissue); ii) neochordal implantation (placement of expanded polytetrafluoroethylene, ePTFE, artificial chordae); annuloplasty (implantation of an annuloplasty ring or pericardial band for annular stabilization).

In cases where significant leaflet tissue is excised (≥10×10 mm), samples will be collected and stored in the institutional BioCor biobank for histological and morphometric analysis. Samples will be decontaminated, cryopreserved, and stored at -80°C. After histological evaluation, all biological material will be destroyed.

Clinical Data Collection Demographic (e.g., age, sex) and clinical data (e.g., diagnosis, medications, comorbidities) will be obtained from medical records and anonymized.

Neural Network Training for Image Segmentation Anonymized RT3DE datasets will be manually segmented by expert operators using advanced image analysis software (e.g., 3D Slicer). A minimum of 150 RT3DE acquisitions will be processed to generate binary masks of the MV annulus, leaflets, and papillary muscles.

These segmented datasets will be used to train a convolutional neural network (CNN), likely based on the 3D U-Net architecture; 70% of the datasets will be used as training data and 30% will be reserved for testing and validation.

The CNN will learn to automatically segment MV structures and generate 3D surface models. Key anatomical features-such as annulus contour, leaflet free margin, commissures, and papillary muscle positions-will be extracted automatically.

Quantitative geometric parameters will include annular area, perimeter, anteroposterior diameter, commissural width, annular height and ellipticity, leaflet dimensions, coaptation zones and billowing extent.

FE Analysis Patient-specific 3D models of the mitral valve will be reconstructed from the segmented RT3DE data. These models will undergo smoothing and remeshing to generate high-quality meshes for structural FE analysis. Chordae tendineae will be modeled based on established anatomical templates and tuned to match physiological lengths. Tissue material properties will be assigned based on published experimental data.

FE simulations will be used to quantify stress distribution on MV leaflets, assess load transfer between leaflets and papillary muscles and evaluate mechanical effects of surgical interventions (e.g., neochordal implantation, annuloplasty) These simulations are retrospective and exploratory; they will not influence surgical decision-making.

Follow-up No post-operative follow-up is required beyond standard clinical care. The study is focused on intraoperative imaging and tissue collection, followed by offline image analysis and computational modeling.

Medical subject headings
Mitral Valve Prolapse

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 36 months

Secondary outcomes (8)
  1. Automated quantification of MV morphometric and functional descriptors

    Ability of the automated pipeline to derive consistent quantification - compared to commercially available solutions for RT3DE processing - of clinically relevant morphometric and functional descriptors of degenerative MVP from RT3DE: i) mitral annular dimensions (projected area, mm²; perimeter, mm; antero-posterior and commissural diameters, mm; height, mm; ellipticity, -); ii) leaflet surface area and billowing volume (mm², mm³); leaflet prolapse height and prolapse volume (mm, mm³); coaptation length and coaptation area (mm, mm²).

    Measured: 36 months

  2. Change in mechanical stress of MV leaflets following surgical MVP repair

    Assessment of change in mechanical stress of MV leaflets following surgical MVP repair using patient-specific FE MV models derived from RT3DE, comparing peak and mean leaflet stress (kPa) between degenerative MVP and post-repair conditions.

    Measured: Up to 1 month after MVP surgical repair

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

    Assessment of changes in the mechanical load transfer to MV sub-apparatus following MV surgical repair using patient-specific FE MV models derived from RT3DE, comparing chordal forces and load transfer to MV papillary muscles (N) between degenerative MVP and post-repair conditions.

    Measured: Up to 1 month after MVP surgical repair

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

    Assessment of change in mechanical stress acting on MV papillary muscles following surgical MVP repair using patient-specific FE MV models derived from RT3DE, comparing peak and mean stress (kPa) between degenerative MVP and post-repair conditions.

    Measured: Up to 1 month after MVP surgical repair

  5. Change in coaptation of MV leaflets following surgical MV repair

    Assessment of change in MV leaflet coaptation following surgical MVP repair using patient-specific FE MV models derived from RT3DE, comparing coaptation length and area (mm, mm²) between degenerative MVP and post-repair conditions.

    Measured: Up to 1 month after MVP surgical repair

  6. Thickness of MV leaflet tissue excised during MVP surgical repair

    Assessment of the thickness (mm) of MV leaflet tissue excised as a consequence of substantial leaflet resection during surgical MVP repair.

    Measured: Up to 2 weeks after MVP surgical repair

  7. Degree of myxomatous degeneration of excised MV leaflet tissue

    Gross and histomorphometric assessment of the degree of myxomatous degeneration of MV leaflet tissue surgically excised during MVP surgical repair, using a semi-quantitative score (0-3): 0 = absent (no gross or histological evidence); 1 = mild (limited focal myxoid/proteoglycan extracellular matrix expansion with mild collagen disorganization); 2 = moderate (diffuse or multifocal myxoid/proteoglycan expansion with moderate collagen fragmentation/disorganization and leaflet thickening); 3 = severe (extensive/diffuse myxoid degeneration with marked extracellular matrix expansion, severe collagen disruption, and pronounced leaflet thickening/redundancy).

    Measured: Up to 2 weeks after MVP surgical repair

  8. Structural histological analysis of excised myxomatous MV leaflet tissue

    Quantitative histological assessment of myxomatous degeneration of excised MV leaflet tissue obtained during mitral valve prolapse (MVP) surgical repair, quantifying collagen and elastin content (% of tissue area) through structural stains.

    Measured: Up to 2 weeks after MVP surgical repair

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2026
  2. Study start26 May 2025
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07384871
Sponsor's protocol ID
AI4MVP
Acronym
AI4MVP
Status last verified
Jan 2026
First submitted
12 Jan 2026
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Mitral Valve Prolapse and Myxomatous Mitral Valve Degeneration, run by IRCCS Policlinico S. Donato at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Francesco Sturla (+390252774353, francesco.sturla@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of automated MV substructure segmentation and extraction of anatomical landmarks from RT3DE (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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