NCT06920745

TriClip CED RWE Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,200 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	The TriClip System	The TriClip System

Timeline

• Start date: 2025-07-08
• Primary completion: 2032-07-01
• Completion: 2032-07-01
• First posted: 2025-04-10
• Last updated: 2025-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study