TriClip CED RWE Study (TRICARE)

Abbott

Status: Enrolling

Conditions: Tricuspid Regurgitation

Treatments: Device: The TriClip System

Study type: Observational

Funder types: Industry

Identifiers

NCT06920745

CL1028170

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,200 participants in 2 patient groups

Treatment Group

Description:

Patients with symptomatic, severe or greater TR who received a T-TEER with the TriClip system

Treatment:

Device: The TriClip System

Control Group

Description:

Patients with symptomatic, severe or greater TR without T-TEER