TriClip CED RWE Study

N/ARecruitingNCT06920745

Abbott Medical Devices2,200 enrolled

Overview

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.

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

2,200

Conditions

Tricuspid Regurgitation

Interventions

The TriClip SystemDEVICE

The TriClip System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Abbott

Santa Clara, California, United States

RECRUITING

Outcomes

Primary Outcomes

Composite of heart failure hospitalization or all-cause mortality

Compare the rate of composite endpoint at 2 years between the treatment and control groups.

Time frame: 2 years

Secondary Outcomes

Tricuspid valve re-intervention

Report the rate at 2 years for the treatment group

Time frame: 2 years

Central Contacts

TRICARE

CONTACT

(408) 845-3000 TRICARE@abbott.com

Data from ClinicalTrials.gov

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