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Novel 3-dimensional Echocardiographic Quantification of Mitral Regurgitant Volume

NCT07528781 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-04-14

No results posted yet for this study

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.

Conditions

  • Moderate or Severe Mitral Regurgitation

Interventions

DEVICE

analysis of the performance of an artificial intelligenced based software for analysis of 3D tranesophageal echocardiography data

The analysis of mitral regurgitation in current practice is based on multiparametric approach of several 2-dimensional Doppler echocardiographic parameters and quantification of mitral regurgitant volume and effective regurgitant orifice area measured with the proxymal isovelocity surface area. This novel algorithm based on artificial intelligence based software may change clinical practice if demonstrates that provides more accurate estimation of the severity of mitral regurgitation.

Sponsors & Collaborators

  • Germans Trias i Pujol Hospital

    lead OTHER

Principal Investigators

  • Carlo F Guarino, MD · Hospital University Germans Trias i Pujol

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-17
Primary Completion
2028-04-30
Completion
2028-04-01
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07528781 on ClinicalTrials.gov