TriClip CED RWE Study

NCT06920745 — Recruiting, 2200 participants, Abbott Medical Devices

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT06920745, acronym TRICARE
Status	Recruiting
Study type	Observational
Enrollment	2200 (Estimated)
Sponsor	Abbott Medical Devices (Industry)
Conditions	Tricuspid Regurgitation
Interventions	The TriClip System (Device)
Dates	start 2025-07-08, primary completion 2032-07-01 (estimated), completion 2032-07-01 (estimated), first posted 2025-04-10, last updated 2025-08-11
Locations	1 site in United States

-Summary

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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Treatment Group		Device: The TriClip System	Patients with symptomatic, severe or greater TR who received a T-TEER with the TriClip system
Control Group			Patients with symptomatic, severe or greater TR without T-TEER

The TriClip System (Device): The TriClip System

+Outcome measures

Primary outcomes

Composite of heart failure hospitalization or all-cause mortality [2 years]: Compare the rate of composite endpoint at 2 years between the treatment and control groups.

Secondary outcomes

Tricuspid valve re-intervention [2 years]: Report the rate at 2 years for the treatment group

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Abbott	Santa Clara, California	United States	Recruiting