TRISCEND JAPAN Study (TRISCEND JAPAN)
Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
About this trial
This is an interventional treatment trial for Tricuspid Valve Regurgitation focused on measuring Transcatheter, Tricuspid Disease, Valve Replacement, Tricuspid Valve
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
Sites / Locations
- Kokura Memorial HospitalRecruiting
- Tokai University HospitalRecruiting
- Sendai Kousei HospitalRecruiting
- National Cerebral and Cardiovascular CenterRecruiting
- Osaka University HospitalRecruiting
- Keio University HospitalRecruiting
- Tokyo Women's Medical University HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Treatment with the Edwards EWJ-202 Transcatheter Tricuspid Valve Replacement System