TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique
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: Transcatheter edge-to-edge repair (TEER).
- Who it may be relevant to
- Registry conditions: Tricuspid Valve Regurgitation. Basic parameters: 18 years — 110 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
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
In this study, patients who have undergone or will undergo a transcatheter edge-to-edge repair (TEER) for tricuspid valve regurgitation (TR) will be followed up for 5 years. The goal of this prospective and retrospective, observational, non-randomized, multicenter registry is to confirm that TEER is a feasible, safe and effective treatment option for TR and to evaluate the long-term efficacy and safety of TEER. The main endpoints are: * Change in tricuspid regurgitation grade: number of patients with a reduction in tricuspid regurgitation score by at least one grade * Composite of major adverse event: number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)
Interventions
- Procedure Transcatheter edge-to-edge repair (TEER)
Minimally invasive transcatheter-based edge-to-edge repair technique for tricuspid regurgitation
Primary outcome measures
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade [Time frame: 30 days]
- Composite of major adverse event [Time frame: 1 year]
Secondary outcome measures (8)
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade at 6 months post-procedure [Time frame: 6 months]
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade 1 year post-procedure [Time frame: 1 year]
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure [Time frame: 2 years]
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade 3 years post-procedure [Time frame: 3 years]
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade 4 years post-procedure [Time frame: 4 years]
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade 5 years post-procedure [Time frame: 5 years]
- Composite of major adverse event at discharge [Time frame: 5 days]
- Composite of major adverse event at 5 years post-procedure [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- At least 18 years old
- Eligible for TEER procedure
- Informed consent signed
Exclusion criteria
- Unwilling to provide informed consent
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
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05577078 · TriBEL