The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult patients
Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
Institutional Heart Team evaluates patient as being at increased operative risk
You may not be if
Patient in need of emergent intervention
Patient who is hemodynamically unstable
Anatomical contraindications for implantation with study device
Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet
