Trials / Recruiting
RecruitingNCT06506942
The TRICURE EFS Study
The TRICURE EFS TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- TRiCares · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcatheter Tricuspid Valve Replacement | Replacement of the tricuspid valve through a transcatheter approach |
Timeline
- Start date
- 2024-09-11
- Primary completion
- 2027-03-01
- Completion
- 2031-03-01
- First posted
- 2024-07-18
- Last updated
- 2026-04-14
Locations
9 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06506942. Inclusion in this directory is not an endorsement.