Overview
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.
Eligibility
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