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TriClip CED RWE Study

TriClip CED RWE Study

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

Study details
    Tricuspid Regurgitation

NCT06920745

Abbott Medical Devices

15 October 2025

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