Heart Failure, Tricuspid Regurgitation, Valvular Heart Disease
Conditions
Keywords
Tricuspid regurgitation, TEER, edge-to-edge repair
Brief summary
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
T-TEER using the PACAL or TriClip device
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Safety | 5 years | periprocedural and in-hospital adverse events |
| Heart Failure Biomarker | 5 years | NT-proBNP level |
| Dyspnea on exertion | 5 years | New York Heart Association (NYHA) functional class |
| Functional capacity | 5 years | 6-minute walk distance (6MWD) |
| Right ventricular size | 5 years | Mid-ventricular diameter of the right ventricle measured by echocardiography |
| Technical success | 5 years | absence of procedural mortality, successful access, delivery and retrieval of the delivery system, successful deployment and positioning, freedom from emergency surgery |
| Tricuspid regurgitation reduction | 5 years | Tricuspid regurgitation severity measured by echocardiography |
| Tricuspid valve stenosis | 5 years | Transvalvular pressure gradient measured by echocardiography |
| Pulmonary hypertension | 5 years | Pulmonary artery pressure measured by echocardiography |
| Right heart congestion | 5 years | Inferior vena cava dimensions measured by echocardiography |
| Hospitalization for heart failure | 5 years | Date and number of heart failure hospitalizations after the index procedure |
| Right ventricular function | 5 years | Right ventricular fractional area change measured by echocardiography |
Countries
Germany