RecruitingNCT07528781

Novel 3-dimensional Echocardiographic Quantification of Mitral Regurgitant Volume


Sponsor

Germans Trias i Pujol Hospital

Enrollment

200 participants

Start Date

Mar 17, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 95 Years

Inclusion Criteria2

  • Patients with at least moderate mitral regurgitation of any etiology
  • Patients with good transesophageal echocardiography image quality

Exclusion Criteria2

  • Patients with prior transcatheter or surgical mitral valve intervention
  • Patients with contraindications for transesophageal echocardiography or cardiac magnetic resonance

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEanalysis 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.


Locations(1)

Hospital University Germans Trias i Pujol

Badalona, Barcelona, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07528781