TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tricuspid Valve Regurgitation
- Sponsor
- AZ Sint-Jan AV
- Enrollment
- 120
- Primary Endpoint
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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)
Investigators
Jan Van der Heyden
Principal Investigator
AZ Sint-Jan AV
Eligibility Criteria
Inclusion Criteria
- •At least 18 years old
- •Eligible for TEER procedure
- •Informed consent signed
Exclusion Criteria
- •Unwilling to provide informed consent
Outcomes
Primary Outcomes
Number of patients with a reduction in tricuspid regurgitation score by at least one grade
Time Frame: 30 days
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 30 days post-procedure
Composite of major adverse event
Time Frame: 1 year
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)
Secondary Outcomes
- Composite of major adverse event at discharge(5 days)
- 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 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(4 years)
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade 5 years post-procedure(5 years)
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade at 6 months post-procedure(6 months)
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure(2 years)
- Composite of major adverse event at 5 years post-procedure(5 years)