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NCT06920745Recruiting

TriClip CED RWE Study

Abbott Medical Devices

Start Date

7/8/2025

Completion Date

7/1/2032

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

The TriClip System

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Conditions

Tricuspid Regurgitation

Locations

Abbott

Santa Clara, California 95054

United States