The TRICURE EFS TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study
TRiCares
Summary
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DeviceTranscatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve through a transcatheter approach
Locations (9)
- Piedmont Healthcare Inc.Atlanta, Georgia
- NorthwesternChicago, Illinois
- University of Michigan Hospital and Health SystemsAnn Arbor, Michigan
- Minneapolis Heart Institute FoundationMinneapolis, Minnesota
- Columbia University Medical Center/ NewYork Presbyterian HospitalNew York, New York
- MontefioreThe Bronx, New York