Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System: Investigation of Safety and Clinical Efficacy Using a Novel Device in Patients With at Least Severe Tricuspid Regurgitation in JAPAN

Edwards Lifesciences8 sites in 1 country45 target enrollmentFebruary 6, 2023

ConditionsTricuspid Valve Regurgitation Heart Valve Diseases Cardiovascular Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tricuspid Valve Regurgitation
Sponsor: Edwards Lifesciences
Enrollment: 45
Locations: 8
Primary Endpoint: All-Cause Mortality
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the Edwards EWJ-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe tricuspid regurgitation despite medical therapy. Subjects will be followed at discharge, 30 days, 6 months and annually through 5 years.

Registry

clinicaltrials.gov

Start Date

February 6, 2023

End Date

September 30, 2029

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Edwards Lifesciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Symptomatic tricuspid regurgitation (TR) despite medical therapy
•TR graded as severe or greater
•Appropriate for transcatheter tricuspid valve replacement per the local heart team

Exclusion Criteria

•Tricuspid valve anatomic contraindications
•Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months
•Hemodynamic instability
•Refractory heart failure requiring advanced intervention
•Currently participating in another investigational study

Outcomes

Primary Outcomes

All-Cause Mortality

Time Frame: 1 year

Participants with all-cause mortality at 1 year from the index procedure

Heart Failure Hospitalization

Time Frame: 1 year

Participants with a heart failure hospitalization at 1 year from the index procedure

Secondary Outcomes

New York Heart Association (NYHA) Functional Class(30 days, 6 months, 12 months, annual for five years)
Health Status as measured by the SF-36 Questionnaire(30 days, 6 months, 12 months, annual for five years)
Health Status as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)(30 days, 6 months, 12 months, annual for five years)
Rates of various adverse events(30 days, 6 months, 12 months, annual for five years)
Rate of Major Adverse Events (MAEs)(30 days)
Reduction in TR grade(30 days, 6 months, 12 months, annual for five years)
Health Status as measured by the EQ-5D-5L Questionnaire(30 days, 6 months, 12 months, annual for five years)
Six-minute walk test(30 days, 6 months, 12 months, annual for five years)