2019-06 TRISCEND Study

Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device

Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System.

Key Inclusion Criteria:

• 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 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 in which the patient has not reached a primary endpoint