2019-06 TRISCEND Study
Trial ID or NCT#
Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device
- - Functional or degenerative TR moderate or greater - Symptomatic despite medical therapy or prior HF hospitalization from TR - The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement Key
- - 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 in which the patient has not reached a primary endpoint
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