An observational study in Mitral Insufficiency and Transcatheter Aortic Valve Replacement, sponsored by Centro Cardiologico Monzino. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Centro Cardiologico Monzino · Observational
Mitral and tricuspid valve disease represents an increasing challenge in the management of patients with heart failure and other cardiovascular diseases. In recent years, the introduction of transcatheter techniques for valve repair and replacement (TVI) has revolutionised the treatment of these diseases, particularly for patients at high surgical risk or who are not candidates for traditional surgery. However, although these procedures are increasingly popular, their long-term effectiveness in terms of cardiac remodelling is still not well understood.
Cardiac magnetic resonance (CMR) techniques, with their advanced capabilities to provide anatomical and functional details of the heart, offer a unique opportunity to assess ventricular remodelling and valve function before and after transcatheter interventions. The ESC guidelines on valvulopathies published in 2021 recommend the use of cardiac magnetic resonance imaging not only to quantify the extent of mitral and tricuspid regurgitation when echocardiography is inconclusive, but also as the gold standard for the assessment of left and right ventricular size and function (limited, however, to the availability of this method in the various centres). Currently, there are few systematic data evaluating the effect of these procedures on CMR-assessed cardiac anatomy and function. This study aims to fill this gap by creating a multicentre registry in which clinical and advanced imaging data, including 3D echocardiography and CMR, are collected to assess the impact of these therapies.
Analysis of data derived from advanced imaging will not only provide a better understanding of the mechanism of operation of transcatheter techniques, but will also provide important information for improving long-term patient outcomes by identifying potential predictors of treatment success or failure.
Mitral and tricuspid valve disease represents an increasing challenge in the management of patients with heart failure and other cardiovascular diseases. In recent years, the introduction of transcatheter techniques for valve repair and replacement (TVI) has revolutionised the treatment of these diseases, particularly for patients at high surgical risk or who are not candidates for traditional surgery. However, although these procedures are increasingly popular, their long-term effectiveness in terms of cardiac remodelling is still not well understood.
Cardiac magnetic resonance (CMR) techniques, with their advanced capabilities to provide anatomical and functional details of the heart, offer a unique opportunity to assess ventricular remodelling and valve function before and after transcatheter interventions. The ESC guidelines on valvulopathies published in 2021 recommend the use of cardiac magnetic resonance imaging not only to quantify the extent of mitral and tricuspid regurgitation when echocardiography is inconclusive, but also as the gold standard for the assessment of left and right ventricular size and function (limited, however, to the availability of this method in the various centres). Currently, there are few systematic data evaluating the effect of these procedures on CMR-assessed cardiac anatomy and function. This study aims to fill this gap by creating a multicentre registry in which clinical and advanced imaging data, including 3D echocardiography and CMR, are collected to assess the impact of these therapies.
Analysis of data derived from advanced imaging will not only provide a better understanding of the mechanism of operation of transcatheter techniques, but will also provide important information for improving long-term patient outcomes by identifying potential predictors of treatment success or failure.
468 studies on the registry are indexed under Mitral Valve Insufficiency; 164 are open to participants now.
This study's planned enrollment of 250 is above the median of 157 across 168 observational studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →Centro Cardiologico Monzino is the lead sponsor of 72 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients who are candidates for transcatheter treatment of severe mitral or tricuspid insufficiency
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cardiac Remodelling
Assessing the impact of mitral and tricuspid transcatheter procedures on cardiac remodelling.
Time frame: 12 months
Analize imaging data
* Compare valve regurgitation quantification by echocardiography with valve regurgitation quantification by MRI using traditional phase contrast and advanced sequences such as 4D flow. * Establish a correlation between structural changes observed by CMR and short- and long-term (at 6 months and 1 year) clinical outcomes. * Analysing imaging data to identify potential predictors of procedure success and improved cardiac function.
Time frame: 12 months
Started Jan 2026 (actual). Primary completion is estimated for Sep 2026, 8 months after the start.
Of 72 non-industry observational studies under Mitral Valve Insufficiency, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 192. This study's planned 8 months is below that.
Counting every sponsor, half of 84 studies reached it within 57 months; a quarter within 26 and three quarters within 192.
How these figures are worked out, and which studies are left out of them.
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Centro Cardiologico Monzino