TriClip CED RWE Study (TRICARE)

August 6, 2025 updated by: Abbott Medical Devices

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Santa Clara, California, United States, 95054
        • Recruiting
        • Abbott
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Real-world patients with symptomatic, severe or greater tricuspid regurgitation in the United States

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment Group
Patients with symptomatic, severe or greater TR who received a T-TEER with the TriClip system
Device: The TriClip System
The TriClip System
Control Group
Patients with symptomatic, severe or greater TR without T-TEER

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tricuspid valve re-intervention
Time Frame: 2 years
Report the rate at 2 years for the treatment group
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2025

Primary Completion (Estimated)

July 1, 2032

Study Completion (Estimated)

July 1, 2032

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 6, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL1028170

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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