NCT07384871 AI-Based Shape and Function Analysis of Mitral Valve Prolapse Using 3D Ultrasound
| NCT ID | NCT07384871 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Policlinico S. Donato |
| Condition | Mitral Valve Prolapse |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-05-26 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-05-26 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07384871 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Valve Prolapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07384871 currently recruiting?
Yes, NCT07384871 is actively recruiting participants. Contact the research team at francesco.sturla@grupposandonato.it for enrollment information.
Where is the NCT07384871 trial being conducted?
This trial is being conducted at San Donato Milanese, Italy.
Who is sponsoring the NCT07384871 clinical trial?
NCT07384871 is sponsored by IRCCS Policlinico S. Donato. The trial plans to enroll 150 participants.