TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique

Study Overview
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Brief Summary
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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)

Official Title
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TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique

Conditions
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Tricuspid Valve Regurgitation

Intervention / Treatment
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* Procedure: Transcatheter edge-to-edge repair (TEER)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old Eligible for TEER procedure Informed consent signed Exclusion Criteria: Unwilling to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TEER<br>Patients with tricuspid valve regurgitation eligible for transcatheter edge-to-edge repair (TEER) | Procedure: Transcatheter edge-to-edge repair (TEER)<br>* Minimally invasive transcatheter-based edge-to-edge repair technique for tricuspid regurgitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with a reduction in tricuspid regurgitation score by at least one grade | Number of patients with a reduction in tricuspid regurgitation score by at least one grade 30 days post-procedure | 30 days | 
| 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) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with a reduction in tricuspid regurgitation score by at least one grade at 6 months post-procedure | Number of patients with a reduction in tricuspid regurgitation score by at least one grade 6 months post-procedure | 6 months | 
| Number of patients with a reduction in tricuspid regurgitation score by at least one grade 1 year post-procedure | Number of patients with a reduction in tricuspid regurgitation score by at least one grade 1 year post-procedure | 1 year | 
| Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure | Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure | 2 years | 
| Number of patients with a reduction in tricuspid regurgitation score by at least one grade 3 years post-procedure | Number of patients with a reduction in tricuspid regurgitation score by at least one grade 3 years post-procedure | 3 years | 
| Number of patients with a reduction in tricuspid regurgitation score by at least one grade 4 years post-procedure | Number of patients with a reduction in tricuspid regurgitation score by at least one grade 4 years post-procedure | 4 years | 
| Number of patients with a reduction in tricuspid regurgitation score by at least one grade 5 years post-procedure | Number of patients with a reduction in tricuspid regurgitation score by at least one grade 5 years post-procedure | 5 years | 
| Composite of major adverse event at discharge | 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) at discharge | 5 days | 
| Composite of major adverse event at 5 years post-procedure | 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) 5 years post-procedure | 5 years |