MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mitral Annular Calcification, Mitral Valve Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering (MAC SEE).
Overview
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
Primary outcome measures
- Quantification of Mitral Calcifications [Time frame: 06/2026]
Secondary outcome measures (1)
- Semiquantitative assessment of mitral calcifications [Time frame: 06/2026]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Centro Cardiologico Monzino; IRCCS — Milan
Identifiers
NCT: NCT07612553 · L2-438