Mitral Annular CalcificationMAC-SEENCT07612553
MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering.
An observational study of Mitral Annular Calcification and Mitral Valve Disease, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Annular Calcification, Mitral Valve Disease
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 17 Dec 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centro Cardiologico Monzino; IRCCS
Milan, Milan, 20138
Chiara Centenaro, 025800203, 0258002031 ext. +39, chiara.centenaro@cardiologicomonzino.it
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Mitral Annular Calcification, Mitral Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 06/2026
Secondary outcomes (1)
Semiquantitative assessment of mitral calcifications
Diagnostic accuracy in the semiquantitative assessment of mitral calcifications through calculation of the "Mitral Annular Calcification Score."
Measured: 06/2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start17 Dec 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Annular CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612553
- Sponsor's protocol ID
- L2-438
- Acronym
- MAC-SEE
- Status last verified
- Dec 2025
- First submitted
- 21 May 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MitrAl Valve Calcium aSsEssmEnt With TrueVue Trans-illumination 3D Rendering (MAC SEE).
- ClinicalTrials.gov ID
- NCT07612553
- Acronym / sponsor ID
- MAC-SEE / L2-438
- Conditions
- Mitral Annular Calcification, Mitral Valve Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Semiquantitative assessment of mitral calcifications
Time frame: 06/2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Annular Calcification and Mitral Valve Disease, run by Centro Cardiologico Monzino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianluca Pontone, MD (0258002574 ext. +39, gianluca.pontone@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of Mitral Calcifications (time frame: 06/2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.