Trials / Active Not Recruiting
Active Not RecruitingNCT06368401
A First in Human Study for the Versa Device for Tricuspid Regurgitation
Transcatheter Tricuspid Repair Utilizing the Versa Vascular Repair System
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Versa Vascular, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical candidates.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Versa Implant | The Versa Vascular Implant and Delivery System consists of a percutaneously delivered, permanent right-atrial implant and the delivery catheter that is used to first position the implant over the native valve orifice and to then place the implant. |
Timeline
- Start date
- 2024-08-05
- Primary completion
- 2024-12-30
- Completion
- 2025-10-02
- First posted
- 2024-04-16
- Last updated
- 2024-12-05
Locations
2 sites across 2 countries: Chile, New Zealand
Source: ClinicalTrials.gov record NCT06368401. Inclusion in this directory is not an endorsement.