Novel 3-dimensional Echocardiographic Quantification of Mitral Regurgitant Volume

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Accuracy of 3DCFQ to quantify mitral regurgitation — 2 years
  To demonstrate that 3D-CFQ software for the quantification of the mitral regurgitation is more reproducible and accurate than the conventional assessment of mitral regurgitation performed with 2-dimensional echocardiography

Trial sites (1)

More Germans Trias i Pujol Hospital trials in Spain