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NCT Number: NCT06920745

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.

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Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abbott

Santa Clara, California, 95054, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The TriClip System

Device

The TriClip System

Primary outcomes

  1. Composite of heart failure hospitalization or all-cause mortality

    Time frame: 2 years

    Compare the rate of composite endpoint at 2 years between the treatment and control groups.

Secondary outcomes

  1. Tricuspid valve re-intervention

    Time frame: 2 years

    Report the rate at 2 years for the treatment group

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: TRICARE

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Apr 10, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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