Menu
Recruiting NCT06920745

TriClip CED RWE Study

— Observational Tricuspid Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The TriClip System.
Who it may be relevant to
Registry conditions: Tricuspid Regurgitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Detailed 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.

Interventions

  • Device The TriClip System
    The TriClip System

Primary outcome measures

  • Composite of heart failure hospitalization or all-cause mortality [Time frame: 2 years]
Secondary outcome measures (1)
  • Tricuspid valve re-intervention [Time frame: 2 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Abbott — Santa Clara

Identifiers

NCT: NCT06920745 · CL1028170

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗