MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering. (MAC-SEE)

MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering (MAC SEE).

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Valve Disease; Mitral Annular Calcification

Detailed Description

This is a non-profit, observational, bidirectional (prospective and retrospective), multicenter study aimed at comparing the diagnostic accuracy of the following modalities:

• Contrast-enhanced computed tomography (CT) (gold standard)
• Three-dimensional transesophageal echocardiography

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Gianluca Pontone, MD; Phone Number: +39 0258002574; Email: gianluca.pontone@cardiologicomonzino.it

Study Locations

• Italy
  • Milan
    • Milan, Milan, Italy, 20138
      • Recruiting
      • Centro Cardiologico Monzino; IRCCS
      • Contact: Chiara Centenaro, 025800203; Phone Number: +39 0258002031; Email: chiara.centenaro@cardiologicomonzino.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria

Retrospective Cohort

• Have already undergone, between February 2025 and September 2025, a contrast-enhanced CT scan and a transesophageal echocardiogram.
• Are ≥ 18 years old.

Prospective Cohort

• Are scheduled to undergo a contrast-enhanced CT scan and a three-dimensional transesophageal echocardiogram as part of their routine clinical assessment for their underlying cardiac condition, with or without mitral annular or leaflet calcifications.
• Are ≥ 18 years old
• who have provided written informed consent to participate in the study

Exclusion Criteria:

Retrospective Cohort

• The following patients will be considered not eligible:
• Patients younger than 18 years.
• Patients whose data are incomplete for the purposes of the planned study assessments
• Patients who have explicitly refused the use of their data for research purposes.

Prospective Cohort

• Patients younger than 18 years.
• Patients who have not signed the study Informed Consent Form

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Prospective Cohort; 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.
Retrospective Cohort; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	06/2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Semiquantitative assessment of mitral calcifications	Diagnostic accuracy in the semiquantitative assessment of mitral calcifications through calculation of the "Mitral Annular Calcification Score."	06/2026

Collaborators and Investigators

• Sponsor: Centro Cardiologico Monzino

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: L2-438

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No