Two-year outcomes after TriClip repair for severe tricuspid regurgitation
TRIClip CoverAge With Evidence Development (CED) Real-World Evidence (RWE) Study (TRICARE)
This project will see if adults with symptomatic severe tricuspid regurgitation who receive the TriClip repair have better two-year health outcomes than similar patients who do not get the repair.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 1 site (Santa Clara, California) |
| Trial ID | NCT06920745 on ClinicalTrials.gov |
What this trial studies
The TRICARE Coverage with Evidence Development program follows adults with symptomatic, severe or greater tricuspid regurgitation who undergo TriClip transcatheter edge-to-edge repair (T‑TEER) and a contemporaneous control group who do not have T‑TEER. It is an observational, non-randomized study that collects clinical outcomes, functional status, and safety events over two years after the index procedure. Eligible patients are adults (≥18 years) with severe or greater TR; patients with prior tricuspid valve replacement or recent aortic/mitral valve interventions are excluded. The study is sponsored by Abbott and uses real-world data to compare the effectiveness and safety of the TriClip system versus standard care.
Who should consider this trial
Good fit: Adults aged 18 or older with symptomatic severe or greater tricuspid regurgitation who have received the TriClip device or are similar patients who have not undergone T‑TEER.
Not a fit: Patients with less-than-severe tricuspid regurgitation, those with prior surgical or transcatheter tricuspid valve replacement, or those who had aortic or mitral valve interventions within 90 days are excluded and unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the findings could support wider access to TriClip repair by showing improved symptoms, quality of life, or clinical outcomes over two years for patients with severe TR.
How similar studies have performed: Previous single-arm and randomized studies of tricuspid T‑TEER, including trials of the TriClip system, have shown symptomatic and echocardiographic improvements, but long-term comparative real-world data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Santa Clara, California
- Abbott — Santa Clara, California, United States (Recruiting)
Study contacts
- Study coordinator: Tricare
- Email: TRICARE@abbott.com
- Phone: (408) 845-3000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.