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NCT Number: NCT07370467

Transcatheter Mitral and Tricuspid Interventions: a Cardiac Magnetic Resonance Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Cardiologico Monzino

Milan, 20131, Italy

Location status: Recruiting

Location contact

Chiara Centenaro

CONTACT

[email protected]

0258002031 ext. +39

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Cardiac Remodelling

    Time frame: 12 months

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

Secondary outcomes

  1. Analize imaging data

    Time frame: 12 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gianluca Pontone, MD

CONTACT

[email protected]

0258002574 ext. +39

Sponsors and collaborators

Lead sponsor

Centro Cardiologico Monzino

Other

Collaborators

  • Centro Hospitalar de Vila Nova de Gaia/Espinho
  • Hospital Álvaro Cunqueiro

Registry information

Official study title

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

Acronym: TEMATIC-MR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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