AI-guided 3D echocardiography measurement of mitral valve leakage
Official title: Novel 3-dimensional Echocardiographic Quantification of Mitral Regurgitant Volume
Run by Germans Trias i Pujol Hospital · NCT07528781 · Data updated 2026-11-12
This test tries an AI tool that measures mitral valve leakage on 3D transesophageal echo in people with moderate or severe mitral regurgitation to see if it matches MRI better than standard 2D echo.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 95 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Germans Trias i Pujol Hospital Academic / other |
| Locations | 1 site (Badalona, Barcelona) |
| Status | Recruiting |
| Started | March 17, 2026 |
| Main results expected | April 2028 |
| Study ends | April 1, 2028 |
| Registry record updated | April 14, 2026 |
| Trial ID | NCT07528781 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with at least moderate mitral regurgitation of any cause who can undergo transesophageal echocardiography and cardiac MRI and who have good TEE image quality, without prior mitral valve interventions, are ideal candidates.
✕Probably not a fit
Patients with poor TEE image quality, prior surgical or transcatheter mitral valve interventions, or contraindications to TEE or MRI are unlikely to receive benefit from the measurements tested here.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project compares an AI-based software that quantifies mitral regurgitant volume from 3D transesophageal echocardiography with conventional 2D echocardiography, using cardiac magnetic resonance (CMR) as the reference standard. Participants with at least moderate mitral regurgitation and good TEE image quality will undergo clinically indicated TEE and CMR and the measurements will be compared for reproducibility and agreement. The main question is whether the 3D-CFQ AI measurement agrees with CMR better than 2D echocardiography does. If agreement is superior, investigators plan to explore using the tool in acute settings such as during transcatheter interventions to guide therapy.
Why it matters
Potential benefit: If successful, this could provide a more accurate and reproducible way to measure mitral regurgitation and help guide decisions about surgery or transcatheter treatment.
How similar studies have gone: Prior comparisons of 3D echocardiography and CMR have shown promising correlations, but AI-driven 3D quantification is relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with at least moderate mitral regurgitation of any etiology * Patients with good transesophageal echocardiography image quality Exclusion Criteria: * Patients with prior transcatheter or surgical mitral valve intervention * Patients with contraindications for transesophageal echocardiography or cardiac magnetic resonance
Where it's running
-
Hospital University Germans Trias i Pujol
Badalona, Barcelona, Spain Recruiting
Study contacts
- Principal investigator: Carlo F Guarino, MD — Hospital University Germans Trias i Pujol
- Study coordinator: Victoria Delgado, Head of Cardiovascular Imaging department, MD, PhD
- Email: cardiologia.germanstrias@gencat.cat
- Phone: +34 93 497 89 15
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.