European Registry of Transcatheter Repair for Tricuspid Regurgitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: T-TEER.
- Who it may be relevant to
- Registry conditions: Tricuspid Regurgitation, Valvular Heart Disease, Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR)
Overview
To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement.
Detailed description
Background and Rationale:
Tricuspid regurgitation (TR) is a major health and economic burden due to high rates of heart failure hospitalizations, morbidity and mortality. Surcial treatment of TR is associated with high procedural and in-hospital mortality. Due to prohibitive surgical risk, a significant proportion of patients historically remained untreted beyond medical therapy. Transcatheter tricuspid valve (TV) repair and replacement techniques (TTVT) now offer a new treatment perspective for these patients. The EuroTR registry aims at optimizing patient selection prior to TTVT and thus treatment quality by collecting respective data in a real-world setting.
Objectives:
To investigate clinical and survival outcome following transcatheter tricuspid valve repair or replacement.
Interventions
- Device T-TEER
T-TEER using the PACAL or TriClip device
Primary outcome measures
- All-cause mortality [Time frame: 5 years]
Secondary outcome measures (12)
- Technical success [Time frame: 5 years]
- Procedural Safety [Time frame: 5 years]
- Heart Failure Biomarker [Time frame: 5 years]
- Dyspnea on exertion [Time frame: 5 years]
- Functional capacity [Time frame: 5 years]
- Right ventricular size [Time frame: 5 years]
- Right ventricular function [Time frame: 5 years]
- Tricuspid regurgitation reduction [Time frame: 5 years]
- Tricuspid valve stenosis [Time frame: 5 years]
- Pulmonary hypertension [Time frame: 5 years]
- Right heart congestion [Time frame: 5 years]
- Hospitalization for heart failure [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Patients treated with one of the following transcatheter devices for TV repair or replacement: PASCAL, TriClip, TricValve, Evoque, LuX-Valve
- Age ≥ 18 years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Germany · 1 center
- LMU Klinikum — Munich
Publications
- Masiero G, Arturi F, Ceni S, Panza A, Kresoja KP, von Stein J, Fortmeier V, Koell B, Rottbauer W, Kassar M, Goebel B, Denti P, Achouh P, Rassaf T, Barreiro-Perez M, Boekstegers P, Ruck A, Zdanyte M, Adamo M, Vincent F, Schlegel P, Rosch S, Wild MG, Besler C, Toggweiler S, Brunner S, Grapsa J, Patterson T, Thiele H, Kister T, Sticchi A, De Carlo M, Voss F, Polzin A, Popolo Rubbio A, Bedogni F, Stol PMID 41235431
Identifiers
NCT: NCT06307262 · EuroTR Registry