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Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment

NCT05825898 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 3500

Last updated 2026-05-08

No results posted yet for this study

Summary

Tricuspid regurgitation (TR) is a public health problem: moderate / severe TR are common, especially in ageing populations, and affect 4% of the population \>75 years old, totaling approximately 1.6 million in the US and 3 million in Europe. TR is associated with an increased risk of mortality and morbidity. Contrasting with TR prevalence and the magnitude of the problem, the vast majority of patients are medically treated with diuretics to relieve their symptoms and a curative surgical treatment for isolated severe TR is seldom performed. Reluctance to perform an ITVS can be explained in the one hand by the limited evidence that TR correction improves outcomes and on the other hand, ITVS is associated to high observed in-hospital mortality rates (≈ 10% remarkably consistent in most series across the literature). Severity of the clinical presentation is the main predictor of outcome after surgery. The TRI-SCORE, is a dedicated, simple and accurate risk score model to predict in-hospital mortality after ITVS that could guide the clinical decision-making process at the individual level. Excellent outcomes can be achieved when patients present with low TRI-SCORE. These results suggest adopting a more pro-active approach for TV interventions, and to intervene earlier in the course of the disease in patients with severe isolated TR, irrespective of TR mechanism / etiology, before the occurrence of advanced / irreversible consequences such as severe RV dilatation / dysfunction, renal and liver failure, and intractable heart failure. Recently transcatheter tricuspid valve interventions (TTVI) have emerged recently as a less invasive option to surgery to cure patients with TR.

What is the best treatment between medical, surgical or transcatheter therapy to consider and the best timing for each patient are not clearly defined. The aim of the study is to compare outcome of patients with significant functional TR according to medical, transcatheter or surgical treatment after matching per TRISCORE.

Conditions

  • Tricuspid Regurgitation

Interventions

PROCEDURE

Surgery or Transcatheter tricuspid valve intervention

Isolated tricuspid valve surgery or Transcatheter tricuspid valve intervention

Sponsors & Collaborators

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • David Messika-Zeitoun · Ottawa Heart Institute Research Corporation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States
  • Austria
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05825898 on ClinicalTrials.gov