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

Enrolling by invitation

Conditions studied: Tricuspid Regurgitation

In brief

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 facts

Study ID

NCT05825898

Run by

Ottawa Heart Institute Research Corporation

People needed

3500

Starts

2022-09-01

Expected to finish

2026-12-01

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Isolated (no left-valvular heart disease (mitral regurgitation) >2)
• AND Functional
• AND Moderate to severe or severe Tricuspid regurgitation

You may not qualify if…

• Congenital valvular disease,
• Previous tricuspid valve intervention,
• Organic tricuspid valvular disease
• Associated valvular heart disease

Where it is running

• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Mount Sinai — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Montefiore Health System — New York, New York, United States
• Vienna Medical University — Vienna, Austria
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada
• IUCPQ — Québec, Canada
• St Michael's Hospital — Toronto, Canada
• St Paul Hospital — Vancouver, Canada
• Amiens University Hospital — Amiens, France
• Henri Mondor Hospital — Créteil, France
• CHU Lille — Lille, France
• Department of Cardiovascular Surgery and Transplantation, Louis Pradel Cardiovascular Hospital — Lyon, France
• APHM, La Timone Hospital, Cardiology Department — Marseille, France
• Department of Cardiology, University Hospital of Nancy-Brabois — Nancy, France
• CHU de Nantes — Nantes, France
• Department of Cardiology, Bichat Claude Bernard Hospital — Paris, France
• CHU de RENNES — Rennes, France
• CHU Charles Nicolle — Rouen, France
• Cardiology Department, Centre Cardiologique du Nord — Saint-Denis, France
• Rangueil University Hospital — Toulouse, France
• Herz- und Diabeteszentrum — Bad Oeynhausen, Germany
• Charité Universitätsmedizin Berlin — Berlin, Germany
• Bonn University Hospital — Bonn, Germany
• University of Cologne — Cologne, Germany

Full record on ClinicalTrials.gov

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