NCT07528781 Novel 3-dimensional Echocardiographic Quantification of Mitral Regurgitant Volume
| NCT ID | NCT07528781 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Germans Trias i Pujol Hospital |
| Condition | Moderate or Severe Mitral Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-03-17 |
| Primary Completion | 2028-04 |
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 200 participants in total. It began in 2026-03-17 with a primary completion date of 2028-04.
⚠ 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
The goal of this observational study is demonstrate that a novel artificial intelligence based software for the quantification of the mitral regurgitation on 3-dimensional transesophageal echocardiography (3D CFQ) is more reproducible and accurate than the conventional assessment of mitral regurgitation performed with 2-dimensional echocardiography. The main question aims to answer is to demonstrate the agreement between 3D-CFQ measurement of the mitral regurgitant volume and the cardiac magnetic resonance measurement of the regurgitant volume is better than the agreement between 2-dimensional echocardiography and cardiac magnetic resonance. If this is demonstrated, we would like to test the accuracy of this tool to be applied in acute settings such as transcatheter interventions to decide the therapy to follow. Participants will undergo clinically indicated transesophageal echocardiography to characterize the mechanism and severity of mitral regurgitation and to cardiac magnetic resonance to be used as reference stadard to define the mitral regurgitation severity.
Eligibility 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
Contact & Investigator
Victoria Delgado, Head of Cardiovascular Imaging department, MD, PhD
✉ cardiologia.germanstrias@gencat.cat📞 +34 93 497 89 15
Carlo F Guarino, MD
PRINCIPAL INVESTIGATOR
Hospital University Germans Trias i Pujol
Frequently Asked Questions
Who can join the NCT07528781 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 95 Years, studying Moderate or Severe Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07528781 currently recruiting?
Yes, NCT07528781 is actively recruiting participants. Contact the research team at cardiologia.germanstrias@gencat.cat for enrollment information.
Where is the NCT07528781 trial being conducted?
This trial is being conducted at Badalona, Spain.
Who is sponsoring the NCT07528781 clinical trial?
NCT07528781 is sponsored by Germans Trias i Pujol Hospital. The principal investigator is Carlo F Guarino, MD at Hospital University Germans Trias i Pujol. The trial plans to enroll 200 participants.