RecruitingNCT06920745
TriClip CED RWE Study
TRIClip CoverAge With Evidence Development (CED) Real-World Evidence (RWE) Study (TRICARE)
Sponsor
Abbott Medical Devices
Enrollment
2,200 participants
Start Date
Jul 8, 2025
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria2
- 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 Criteria3
- 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
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Interventions
DEVICEThe TriClip System
The TriClip System
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06920745
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