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Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05006443
Enrollment
75
Registered
2021-08-16
Start date
2022-01-14
Completion date
2025-04-30
Last updated
2025-05-13

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

Conditions

Tricuspid Regurgitation

Brief summary

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).

Detailed description

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.

Interventions

a non-invasive assessment to determine severity of tricuspid regurgitation

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Moderate or more tricuspid regurgitation

Exclusion criteria

1. Prior tricuspid valve prosthesis 2. Pacemaker/defibrillator that would impede MRI imaging 3. Planned tricuspid valve surgery 4. Primary liver pathology

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Severity of tricuspid regurgitation by cardiac magnetic resonance imaging1 yearIncidence of severity of TR by CMR as compared with current gold standard (TTE)

Secondary

MeasureTime frameDescription
Correlation between severity of Tricuspid regurgitation by cardiac magnetic resonance imaging vs. elastography1 yearCorrelation between severity of TR by CMR vs. echocardiography with 1-year composite endpoint of death, heart failure hospitalization, or tricuspid valve surgery.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026