Trials / Recruiting
RecruitingNCT06581471
The TRICURE EU Pivotal Study
The TRICURE EU PIVOTAL TRiCares Topaz Transcatheter TRICUspid Heart Valve REplacement System EUropean PIVOTAL Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (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
- 2024-08-29
- Primary completion
- 2026-10-30
- Completion
- 2030-12-30
- First posted
- 2024-09-03
- Last updated
- 2026-04-15
Locations
8 sites across 2 countries: Belgium, Germany
Source: ClinicalTrials.gov record NCT06581471. Inclusion in this directory is not an endorsement.