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Transcatheter Mitral and Tricuspid Interventions: a Cardiac Magnetic Resonance Study

TEMATIC-MR: Transcatheter Mitral and Tricuspid Interventions: a Cardiac Magnetic Resonance Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07370467
Acronym
TEMATIC-MR
Enrollment
250
Registered
2026-01-27
Start date
2026-01-30
Completion date
2026-09-30
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Insufficiency, Transcatheter Aortic Valve Replacement

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Centro Cardiologico Monzino
Lead SponsorOTHER
Hospital Álvaro Cunqueiro
CollaboratorOTHER
Centro Hospitalar de Vila Nova de Gaia/Espinho
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Cardiac Remodelling12 monthsAssessing the impact of mitral and tricuspid transcatheter procedures on cardiac remodelling.

Secondary

MeasureTime frameDescription
Analize imaging data12 months* 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.

Countries

Italy

Contacts

CONTACTGianluca Pontone, MD
gianluca.pontone@cardiologicomonzino.it0258002574

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026