Tricuspid Valve Regurgitation
Conditions
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)
Interventions
Minimally invasive transcatheter-based edge-to-edge repair technique for tricuspid regurgitation
Sponsors
AZ Sint-Jan AV
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* At least 18 years old * Eligible for TEER procedure * Informed consent signed
Exclusion criteria
* Unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with a reduction in tricuspid regurgitation score by at least one grade | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 2 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 3 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 4 years post-procedure |
| 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 6 months post-procedure |
| Composite of major adverse event at discharge | 5 days | 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 |
| Composite of major adverse event at 5 years post-procedure | 5 years | 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 |
| 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 5 years 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 1 year post-procedure |
Outcome results
None listed