TRISCEND JAPAN Study

Edwards Lifesciences

Status: Active, not recruiting

Conditions: Heart Valve Diseases; Cardiovascular Diseases; Tricuspid Valve Regurgitation

Treatments: Device: Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05760989

2021-12

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Treatment with the Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System

Experimental group

Treatment:

Device: Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System