The TRICURE EFS TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Transcatheter Tricuspid Valve Replacement
- Conditions
- Not specified
- Sponsor
- TRiCares
- Enrollment
- 15
- Locations
- 17
- Primary Endpoint
- Composite of MAE
- Status
- Recruiting
- Last Updated
- 18 days ago
Overview
Brief Summary
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Detailed 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Transcatheter Tricuspid Valve Replacement
Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System
Intervention: Transcatheter Tricuspid Valve Replacement
Outcomes
Primary Outcomes
Composite of MAE
Time Frame: 30 day post-intervention
Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications.
Device Success
Time Frame: immediately post-intervention
Device success defined as a reduction in tricuspid regurgitation immediately post-intervention
Secondary Outcomes
- Six minute walk test(30 days, 6 months, annual for five years post-intervention)
- Reduction in Tricuspid Regurgitation (TR) Grade(30 days, 6 months, annual for five years post-intervention)
- New York Heart Association (NYHA) Function Class(30 days, 6 months, annual for five years post-intervention)