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NCT Number: NCT07612553

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

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.

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Key information

Conditions

Mitral Annular Calcification Mitral Valve Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Cardiologico Monzino; IRCCS

Milan, 20138, Italy

Location status: Recruiting

Location contact

Chiara Centenaro, 025800203

CONTACT

[email protected]

0258002031 ext. +39

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Quantification of Mitral Calcifications

    Time frame: 06/2026

    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.

Secondary outcomes

  1. Semiquantitative assessment of mitral calcifications

    Time frame: 06/2026

    Diagnostic accuracy in the semiquantitative assessment of mitral calcifications through calculation of the "Mitral Annular Calcification Score."

Study contacts

Contact information is provided by the study sponsor or research team.

Gianluca Pontone, MD

CONTACT

[email protected]

0258002574 ext. +39

Sponsors and collaborators

Lead sponsor

Centro Cardiologico Monzino

Other

Registry information

Official study title

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

Acronym: MAC-SEE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 28, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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