An observational study in Mitral Annular Calcification and Mitral Valve Disease, sponsored by Centro Cardiologico Monzino. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Centro Cardiologico Monzino · Observational
The study of calcifications involving the mitral valve is extremely important for the planning of both surgical and percutaneous procedures. Computed tomography (CT) is the non-invasive imaging modality considered the gold standard for the assessment of mitral valve calcifications, thanks to its high spatial resolution and the strong X-ray attenuation of calcium deposits.
Echocardiography has traditionally played a limited role in the evaluation of mitral valve calcifications, particularly with three-dimensional imaging. Three-dimensional transesophageal echocardiographic rendering with TrueVue transillumination (Philips Medical Systems, Eindhoven, NL) can provide additional information on the location and extent of calcium on the mitral valve by allowing the placement of a virtual light source beneath the mitral valve.
Specifically, the TrueVue system is an advanced software module integrated into Philips echographic equipment that uses data acquired by the transesophageal probe to generate photorealistic images of the heart.
Therefore, the ability to evaluate the position and extent of calcifications through transesophageal echocardiography may represent an important step forward for echocardiographic imaging.
This is a non-profit, observational, bidirectional (prospective and retrospective), multicenter study aimed at comparing the diagnostic accuracy of the following modalities:
Centro Cardiologico Monzino is the lead sponsor of 72 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study plans to analyze data from a total of 100 patients (approximately 50% retrospective and 50% prospective) who have already undergone, or are scheduled to undergo, a contrast-enhanced CT scan and a transesophageal echocardiogram, according to routine clinical practice and for any clinical indication related to their underlying condition.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Retrospective Cohort
Prospective Cohort
Exclusion Criteria:
Retrospective Cohort
Prospective Cohort
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the prospective part of the study, adult patients who, for any clinical indication and as part of routine clinical care, are scheduled to undergo both contrast-enhanced chest computed tomography (CT) and three-dimensional transesophageal echocardiography (3D TEE) will be consecutively enrolled. As this is an observational study, participants will not undergo any additional diagnostic procedures or receive any additional treatments beyond standard clinical practice. Data will be collected from examinations performed according to routine care.
In the retrospective part of the study, clinical and imaging data will be collected from adult patients who have already undergone both contrast-enhanced chest computed tomography (CT) and three-dimensional transesophageal echocardiography (3D TEE) as part of routine clinical care. Eligible examinations performed between February 2025 and September 2025 will be reviewed. Only patients with complete data required for the study analyses will be included. No additional procedures or interventions will be performed, as the study is observational and based exclusively on existing clinical records.
Quantification of Mitral Calcifications
Diagnostic accuracy in the quantification of mitral calcifications, assessed through qualitative visual evaluation and defined by the presence of calcium involving: (1) the mitral valve; (2) the mitral annulus, with or without differentiation of the mitral scallops; and (3) the mitral leaflets, with or without differentiation of the mitral scallops.
Time frame: 06/2026
Semiquantitative assessment of mitral calcifications
Diagnostic accuracy in the semiquantitative assessment of mitral calcifications through calculation of the "Mitral Annular Calcification Score."
Time frame: 06/2026
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Centro Cardiologico Monzino