Transcatheter Mitral and Tricuspid Interventions: a Cardiac Magnetic Resonance Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro Cardiologico Monzino

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 anni

Signing informed consent

Patients who are candidates for transcatheter mitral or tricuspid surgery (TEER, TTVR).

Disqualifiers

Age < 18 years

Contraindications to CMR or administration of contrast medium (gadolinium)

Trial population

Consecutive patients who are candidates for transcatheter treatment of severe mitral or tricuspid insufficiency

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Cardiac Remodelling

Assessing the impact of mitral and tricuspid transcatheter procedures on cardiac remodelling.

Time frame
12 months

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centro Cardiologico Monzino

Lead sponsor

Hospital Álvaro Cunqueiro

Collaborator

Centro Hospitalar de Vila Nova de Gaia/Espinho

Collaborator