Novel 3-dimensional Echocardiographic Quantification of Mitral Regurgitant Volume
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-95
SponsorGermans Trias i Pujol Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients with at least moderate mitral regurgitation of any etiology
Patients with good transesophageal echocardiography image quality
Disqualifiers
Patients with prior transcatheter or surgical mitral valve intervention
Patients with contraindications for transesophageal echocardiography or cardiac magnetic resonance
Trial population
Patients 18 years old or older with at least moderate mitral regurgitation of any etiology (primary or secondary) who are referred for transesophageal echocardiographic evaluation will be included. During the same day or within 5 days of transesophageal echocardiography, patients with undergo cardiac magnetic resonance. Patients with multiple regurgitant jets will not be excluded. In addition, patients with concomitant mitral stenosis, or other valvular heart disease will not be excluded. Patients with prior mitral valve intervention or bad image quality for analysis of 3D color flow or cardiac magnetic resonance will be excluded. Patients with contraindications for cardiac magnetic resonance will be excluded.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
analysis of the performance of an artificial intelligenced based software for analysis of 3D tranesophageal echocardiography data
DeviceThe 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Consecutive patients with at least moderate mitral regurgitaiton1 intervention
Trial outcomes
Primary outcomes
1
Accuracy of 3DCFQ to quantify mitral regurgitation
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
Time frame
2 yearsSecondary outcomes
1
Validation of 3DCFQ to quantify mitral regurgitation
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
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov