Mitral Valve Calcification Imaging with TrueVue 3D Light Rendering

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, multicenter study compares imaging methods used before mitral valve procedures. It looks at contrast-enhanced CT as the reference standard and 3D transesophageal echocardiography with TrueVue transillumination for detecting calcium on the mitral valve. The study includes retrospective data and prospective patients who will undergo both imaging modalities as part of routine care. Eligible adults are those who have or will have CT and TEE with or without calcifications related to the mitral valve. Data privacy and consent are required for prospective participants.

Why it matters

Who can join: the full rules

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

Where it's running

• Centro Cardiologico Monzino; IRCCS
  Milan, Milan, Italy Recruiting

Study contacts

• Study coordinator: Gianluca Pontone, MD
• Email: gianluca.pontone@cardiologicomonzino.it
• Phone: 0258002574

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry for optimal treatment options for mitral valve issues

  This study looks at how well different treatments work for people with serious mitral valve problems, comparing those who had a new valve implanted to those who weren't able to get that treatment.

  Recruiting at 43 sites Universitätsklinikum Hamburg-Eppendorf · Tucson, Arizona and 42 other locations · NCT04688190

• MITRAL II Pivotal: Transcatheter mitral valve replacement for severe mitral annular calcification

  This trial tests whether placing an Edwards SAPIEN transcatheter valve through a transseptal approach helps high-surgical-risk adults with severe mitral annular calcification and symptomatic mitral valve dysfunction.

  Recruiting at 14 sites Mayo Clinic · Gilbert, Arizona and 16 other locations · NCT04408430

• MRace Implant: A first look at fixing the mitral valve to reduce regurgitation

  This single-arm study tests whether the MRace Implant and Delivery System can safely place a prosthesis to reduce severe mitral regurgitation in high-risk patients who may not be good candidates for open-heart surgery.

  Recruiting at 4 sites Polares Medical SA · Tbilisi and 3 other locations · NCT07796659

• Tracking progression and consequences of heart valve disease

  This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.

  Recruiting at 15 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Fuzhou, Fujian and 14 other locations · NCT07267117

• Surgical implantation of a polymer prosthetic mitral or aortic valve

  This will test a surgically implanted polymer heart valve to see if it is safe and works well for adults who need mitral or aortic valve replacement.

  Recruiting Mitrassist Lifesciences Limited Co., Ltd. · Shanghai, Shanghai Municipality · NCT07097740

• Abbott Cephea registry for mitral valve disease

  Collects clinical information on adults with symptomatic mitral valve disease to see how correcting the valve with the Cephea system affects outcomes for patients who might be candidates for transcatheter mitral valve replacement.

  Recruiting at 24 sites Abbott Medical Devices · Birmingham, Alabama and 23 other locations · NCT07069673

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.