Trials / Active Not Recruiting
Active Not RecruitingNCT05126030
The TRICURE First in Human Trial
TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First in Human Trial
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- TRiCares · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
Detailed description
The TRiCares Topaz Prosthesis is intended to replace a diseased tricuspid heart valve via a transcatheter approach without removing the native valve.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Topaz TTVR System | Transcatheter tricuspid heart valve replacement |
Timeline
- Start date
- 2022-07-15
- Primary completion
- 2025-03-01
- Completion
- 2029-05-15
- First posted
- 2021-11-18
- Last updated
- 2025-03-26
Locations
11 sites across 2 countries: Belgium, France
Source: ClinicalTrials.gov record NCT05126030. Inclusion in this directory is not an endorsement.