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MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering.

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07612553
Acronym
MAC-SEE
Enrollment
100
Registered
2026-05-28
Start date
2025-12-17
Completion date
2026-10-01
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Annular Calcification, Mitral Valve Disease

Brief summary

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.

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

Interventions

None listed

Sponsors

Centro Cardiologico Monzino
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quantification of Mitral Calcifications06/2026Diagnostic 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.

Secondary

MeasureTime frameDescription
Semiquantitative assessment of mitral calcifications06/2026Diagnostic accuracy in the semiquantitative assessment of mitral calcifications through calculation of the "Mitral Annular Calcification Score."

Countries

Italy

Contacts

CONTACTGianluca Pontone, MD
gianluca.pontone@cardiologicomonzino.it0258002574

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026