The TRICURE EU Pivotal Study
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
| Condition(s) | Tricuspid Valve Regurgitation, Heart Valve Disease, Cardiovascular Diseases |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System |
| Who can participate | Inclusion Criteria: * Adult patients * Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential) * Institutional Heart Team evaluates patient as being at increased operative risk Exclusion Criteria: * Patient in need of emergent intervention * Patient who is hemodynamically unstable * Anatomical contraindications for implantation with study device * Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | TRiCares |
| Locations | Aalst, Belgium; Antwerp, Belgium; Brussels, Belgium; Brussels, Belgium; Liège, Belgium; Roeselare, Belgium (+2 more sites) |
| Start date | 2024-08-29 |
| NCT ID | NCT06581471 |
| Official listing | https://clinicaltrials.gov/study/NCT06581471 |