Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)

Conditions studied

Tricuspid Regurgitation, Tricuspid Regurgitation Functional

What is being tested

• DEVICE: Trillium™

What it measures

• Rate of Major Adverse Events [Safety endpoint], Rate of device or procedure-related Major Adverse Events (MAEs) And Rate of unplanned surgery or re-intervention due to a life-threatening device or procedure failure, at the end of the procedure, at discharge - typically within a week, and 30 days
• Technical Performance, Successful access, delivery, and retrieval of the Trillium™ delivery system, device is anchored both in SVC and IVC \[at the end of the procedure\] And No need for re-intervention due to device valve regurgitation or para-stent leak \[at discharge, and 30 days\], at the end of the procedure, at discharge - typically within a week, and 30 days

Working with

Innoventric Inc.