Transcatheter Mitral and Tricuspid Interventions and Cardiac MRI Registry
Official title: TEMATIC-MR: Transcatheter Mitral and Tricuspid Interventions: a Cardiac Magnetic Resonance Study
Run by Centro Cardiologico Monzino · NCT07370467 · Data updated 2026-11-12
This study will collect imaging and clinical data from adults undergoing transcatheter mitral or tricuspid procedures to see how their heart structure and function change over time using MRI and advanced ultrasound.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Centro Cardiologico Monzino Academic / other |
| Locations | 1 site (Milan, Milan) |
| Status | Recruiting |
| Started | January 30, 2026 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT07370467 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18 years and older) who are candidates for transcatheter mitral or tricuspid surgery (TEER or TTVR) and can undergo cardiac MRI.
✕Probably not a fit
Individuals unable to undergo MRI or with contraindications to gadolinium contrast may not benefit from the imaging components of the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter registry collects clinical and advanced imaging data before and after transcatheter mitral or tricuspid interventions. It utilizes cardiac magnetic resonance and 3D echocardiography to characterize ventricular remodelling and valve function. The goal is to better understand how these procedures affect heart anatomy and physiology in real-world patients at risk from traditional surgery. Data will be gathered across participating centers to identify patterns and inform future practice. The study is observational and does not specify an intervention arm beyond the planned transcatheter procedures.
Why it matters
Potential benefit: If successful, the registry could clarify how transcatheter valve procedures impact heart structure and function, potentially guiding patient selection and follow-up imaging strategies.
How similar studies have gone: Previous research suggests imaging-guided assessment can reveal insights into remodelling after valve interventions, but multicenter registry data for CMR-based remodelling after TEER/TTVR remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 anni * Signing informed consent * Patients who are candidates for transcatheter mitral or tricuspid surgery (TEER, TTVR). Exclusion Criteria: * Age \< 18 years * Contraindications to CMR or administration of contrast medium (gadolinium)
Where it's running
-
Centro Cardiologico Monzino
Milan, Milan, Italy Recruiting
Study contacts
- Study coordinator: Gianluca Pontone, MD
- Email: gianluca.pontone@cardiologicomonzino.it
- Phone: 0258002574
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.