TriClip CED RWE Study
This Coverage with Evidence Development (CED) study evaluates the long-term health outcomes of patients with symptomatic, severe or greater Tricuspid Regurgitation who received a Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) procedure using the TriClip system.
| Condition(s) | Tricuspid Regurgitation |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | This Coverage with Evidence Development (CED) study evaluates the long-term health outcomes of patients with symptomatic, severe or greater Tricuspid Regurgitation who received a Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) procedure using the TriClip system. |
| Who can participate | Inclusion Criteria: * Patients ≥ 18 years of age at time of implant * Patients with symptomatic, severe or greater Tricuspid Regurgitation who have received the TriClip system (treatment group) or have not undergone T-TEER (control group) Exclusion Criteria: * Patients with less than severe Tricuspid Regurgitation * Patients with a prior history of surgical or transcatheter tricuspid valve replacement * Patients with a surgical or transcatheter aortic or mitral valve intervention within 90 days prior to index |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Abbott Medical Devices |
| Locations | Santa Clara, California, United States |
| Start date | 2025-07-08 |
| NCT ID | NCT06920745 |
| Official listing | https://clinicaltrials.gov/study/NCT06920745 |