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OpenTrials
Completed

NCT Number: NCT05006443

Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

The purpose of this research is to assess the severity of tricuspid regurgitation (a disorder in which the tricuspid valve in the heart does not close tight enough) using cardiac magnetic resonance imaging (MRI).

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Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

40 patients with moderate or more TR on echocardiography will undergo CMR/MRE with contrast to assess TR severity, and the associated extra-valvular cardiac and liver abnormalities as shown in the flow diagram below. Patients will continue their clinical management by their primary physicians as per the standards of care. 1-year follow up will be conducted via phone to inquire about patient's vital status (dead/alive), symptoms and hospitalizations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Moderate or more tricuspid regurgitation

Exclusion criteria

  • Prior tricuspid valve prosthesis
  • Pacemaker/defibrillator that would impede MRI imaging
  • Planned tricuspid valve surgery
  • Primary liver pathology

Treatment and study plan

Cardiac magnetic resonance

Diagnostic Test

a non-invasive assessment to determine severity of tricuspid regurgitation

Other names: Cardiac MRI

Primary outcomes

  1. Incidence of Severity of tricuspid regurgitation by cardiac magnetic resonance imaging

    Time frame: 1 year

    Incidence of severity of TR by CMR as compared with current gold standard (TTE)

Secondary outcomes

  1. Correlation between severity of Tricuspid regurgitation by cardiac magnetic resonance imaging vs. elastography

    Time frame: 1 year

    Correlation between severity of TR by CMR vs. echocardiography with 1-year composite endpoint of death, heart failure hospitalization, or tricuspid valve surgery.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Aug 16, 2021
Registry last updated
May 13, 2025

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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