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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEER | Patients with tricuspid valve regurgitation eligible for transcatheter edge-to-edge repair (TEER) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter edge-to-edge repair (TEER) | Procedure | Minimally invasive transcatheter-based edge-to-edge repair technique for tricuspid regurgitation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with tricuspid valve regurgitation eligible for transcatheter edge-to-edge repair
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 |