The TRICURE EU Pivotal Study

The TRICURE EU PIVOTAL TRiCares Topaz Transcatheter TRICUspid Heart Valve REplacement System EUropean PIVOTAL Study

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

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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