European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tricuspid Regurgitation
- Sponsor
- LMU Klinikum
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- All-cause mortality
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Prof. Dr. med. Jörg Hausleiter
Deputy chief
LMU Klinikum
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
All-cause mortality
Time Frame: 5 years
Secondary Outcomes
- Technical success(5 years)
- Procedural Safety(5 years)
- Dyspnea on exertion(5 years)
- Right ventricular function(5 years)
- Tricuspid regurgitation reduction(5 years)
- Tricuspid valve stenosis(5 years)
- Heart Failure Biomarker(5 years)
- Pulmonary hypertension(5 years)
- Right ventricular size(5 years)
- Functional capacity(5 years)
- Right heart congestion(5 years)
- Hospitalization for heart failure(5 years)