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Clinical trial Recruiting at 1 site Observational Ages 18 and up

Two-year outcomes after TriClip repair for severe tricuspid regurgitation

Official title: TRIClip CoverAge With Evidence Development (CED) Real-World Evidence (RWE) Study (TRICARE)

Run by Abbott Medical Devices · NCT06920745 · Data updated 2026-11-12

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.

More Tricuspid Regurgitation trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment2200 (estimated)
SponsorAbbott Medical Devices
Industry-sponsored
Locations1 site (Santa Clara, California)
StatusRecruiting
StartedJuly 8, 2025
Main results expectedJuly 2032
Study endsJuly 2032
Registry record updatedAugust 11, 2025
Trial IDNCT06920745 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Abbott
    Santa Clara, California, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Tricuspid Regurgitation 39Abbott Medical Devices 27
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.