Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment
TRIGISTRY
1 other identifier
observational
3,500
10 countries
44
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Longer than P75 for all trials
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 11, 2023
CompletedFirst Posted
Study publicly available on registry
April 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 8, 2026
April 1, 2026
4.3 years
April 11, 2023
May 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Survival at 2 years
Mortality
2 years
Secondary Outcomes (2)
Survival free of heart failure admission at 2 years
2 years
Survival and heart failure readmissions
up to 10 years
Study Arms (3)
Conservative management
Patients with TR who did not undergo a tricuspid valve intervention
Isolated tricuspid valve surgery
Patients with TR who underwent a Isolated tricuspid valve surgery.
Transcatheter tricuspid valve intervention
Patients with TR who underwent a transcatheter tricuspid valve intervention.
Interventions
Isolated tricuspid valve surgery or Transcatheter tricuspid valve intervention
Eligibility Criteria
The investigators will enroll 3 populations of patients with isolated functional TR * Patients who remained under conservative management * Patients who underwent an isolated valve surgery * Patients who underwent a transcatheter valve intervention
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Mount Sinai
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Health System
New York, New York, 10467, United States
Vienna Medical University
Vienna, Austria
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, 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
Cardiovascular center Frankfurt
Frankfurt, Germany
Albertinen Heart and Vascular Center
Hamburg, Germany
Asklepios clinic Sankt Georg
Hamburg, Germany
University Heart and Vascular Center
Hamburg, Germany
Leipzig University Hospital
Leipzig, Germany
University Medical Center of Mainz
Mainz, Germany
Munich Großhadern
Munich, Germany
Tel Aviv Medical center
Tel Aviv, Israel
Instituto Auxologico Italiano, IRCCS
Milan, Italy
San Raffaele University Hospital
Milan, Italy
Leiden University Medical center
Leiden, Netherlands
Hospital 12 de Octubre
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Puerta de Hierro
Madrid, Spain
Hopital Universitaire de Bern
Bern, Switzerland
Istituto Cardiocentro Ticino
Lugano, Switzerland
Zurich Heart Center
Zurich, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Messika-Zeitoun
Ottawa Heart Institute Research Corporation
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2023
First Posted
April 24, 2023
Study Start
September 1, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
A steering committee will organize the publication plan