Clinical Trial

Novel 3-dimensional Echocardiographic Quantification of Mitral Regurgitant Volume

Study acronym: AIM_3D
Recruiting
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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.
Trial Details
NCT Number NCT07528781
Lead Sponsor Germans Trias i Pujol Hospital
Conditions Moderate or Severe Mitral Regurgitation
Enrollment 200 participants
Start Date 2026-03-17
Primary Completion 2028-04 (estimated)
Study Completion 2028-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-14