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

NCT07612553 | Recruiting

• 1 other identifier: L2-438
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Annular Calcification; Mitral Valve Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Semiquantitative assessment of mitral calcifications

  06/2026

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead

Study Sites (1)

Centro Cardiologico Monzino; IRCCS

Milan, Milan, 20138, Italy

RECRUITING

Central Study Contacts

Gianluca Pontone, MD

CONTACT

0258002574; gianluca.pontone@cardiologicomonzino.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: December 17, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: May 28, 2026

Record last verified: 2025-12

Locations

IT (1)