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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Ottawa Heart Institute Research Corporation
Study ID
NCT05825898
Status
Enrolling By Invitation

Conditions

  • Tricuspid Regurgitation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Surgery or Transcatheter tricuspid valve intervention — PROCEDURE
    Isolated tricuspid valve surgery or Transcatheter tricuspid valve intervention

Study Details

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.

Key Dates

Start date
Sep 1, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
3,500 participants (estimated)

Arms

  • Arm: Conservative management
    Patients with TR who did not undergo a tricuspid valve intervention
  • Arm: Isolated tricuspid valve surgery
    Patients with TR who underwent a Isolated tricuspid valve surgery.
  • Arm: Transcatheter tricuspid valve intervention
    Patients with TR who underwent a transcatheter tricuspid valve intervention.

Primary Outcome Measure

Survival at 2 years [ Time Frame: 2 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Mayo Clinic RochesterRochesterMinnesota55905-
Columbia University Medical CenterNew YorkNew York10032-
Montefiore Health SystemNew YorkNew York10467-
Mount SinaiNew YorkNew York10029-

Find similar trials in Rochester, MN

By research site
Mayo Clinic Rochester· Rochester, MNColumbia University Medical Center· New York, NYMontefiore Health System· New York, NYMount Sinai· New York, NY

Related Studies