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ENROLLING BY INVITATION
NCT05825898

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

Sponsor: Ottawa Heart Institute Research Corporation

View on ClinicalTrials.gov

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.

Official title: Outcome of Patients with Severe Functional Tricuspid Regurgitation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

3500

Start Date

2022-09-01

Completion Date

2026-12

Last Updated

2025-03-28

Healthy Volunteers

No

Interventions

PROCEDURE

Surgery or Transcatheter tricuspid valve intervention

Isolated tricuspid valve surgery or Transcatheter tricuspid valve intervention

Locations (44)

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

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