AI and 3D ultrasound mapping of mitral valve prolapse shape and function.
AI-Based Morphological Analysis and Biomechanical Numerical Evaluation of Mitral Valve Prolapse (MVP) From Real-Time 3D Echocardiography (RT3DE)
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 type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese) |
| Trial ID | NCT07384871 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
San Donato Milanese
- IRCCS Policlinico San Donato — San Donato Milanese, Italy (Recruiting)
Study contacts
- Study coordinator: Francesco Sturla
- Email: francesco.sturla@grupposandonato.it
- Phone: +390252774353
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.