TRIClip CoverAge With Evidence Development (CED) Real-World Evidence (RWE) Study (TRICARE)
Abbott Medical Devices
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.
Description
The TRICARE will assess 2-year effectiveness in patients with symptomatic, severe or greater TR who undergo Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) with the TriClip system, as compared to a contemporaneous control of patients without T-TEER.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DeviceThe TriClip System
The TriClip System
Location
- AbbottSanta Clara, California