To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement.
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.
Study Type
OBSERVATIONAL
Enrollment
3,000
T-TEER using the PACAL or TriClip device
LMU Klinikum
Munich, Bavaria, Germany
RECRUITINGAll-cause mortality
Time frame: 5 years
Technical success
absence of procedural mortality, successful access, delivery and retrieval of the delivery system, successful deployment and positioning, freedom from emergency surgery
Time frame: 5 years
Procedural Safety
periprocedural and in-hospital adverse events
Time frame: 5 years
Heart Failure Biomarker
NT-proBNP level
Time frame: 5 years
Dyspnea on exertion
New York Heart Association (NYHA) functional class
Time frame: 5 years
Functional capacity
6-minute walk distance (6MWD)
Time frame: 5 years
Right ventricular size
Mid-ventricular diameter of the right ventricle measured by echocardiography
Time frame: 5 years
Right ventricular function
Right ventricular fractional area change measured by echocardiography
Time frame: 5 years
Tricuspid regurgitation reduction
Tricuspid regurgitation severity measured by echocardiography
Time frame: 5 years
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Tricuspid valve stenosis
Transvalvular pressure gradient measured by echocardiography
Time frame: 5 years
Pulmonary hypertension
Pulmonary artery pressure measured by echocardiography
Time frame: 5 years
Right heart congestion
Inferior vena cava dimensions measured by echocardiography
Time frame: 5 years
Hospitalization for heart failure
Date and number of heart failure hospitalizations after the index procedure
Time frame: 5 years