Trials / Active Not Recruiting
Active Not RecruitingNCT06119607
PILot Aortic Triflo Valve Study
A Prospective, Single-arm, Exploratory Clinical Investigation to Assess Preliminary Safety and Collect Performance and Effectiveness Data of the TRIFLO Heart Valve
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Novostia SA · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, single arm, exploratory clinical investigation to assess preliminary safety and collect performance and effectiveness data of the TRIFLO Heart Valve.
Detailed description
Up to 10 Subjects requiring aortic valve replacement of the native valve will be included in this First in Human clinical investigation on the TRIFLO Heart Valve device in Europe. The study is prospective, single-arm-open-label-non-randomized.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TRIFLO Heart Valve | Surgical Aortic Valve Replacement - Mechanical Valve |
Timeline
- Start date
- 2023-11-30
- Primary completion
- 2025-12-01
- Completion
- 2029-06-01
- First posted
- 2023-11-07
- Last updated
- 2025-08-15
Locations
1 site across 1 country: Lithuania
Source: ClinicalTrials.gov record NCT06119607. Inclusion in this directory is not an endorsement.