Trials / Recruiting
RecruitingNCT04775108
First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System
First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System (MINERVA FIH)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Epygon · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
The EPYGON VALVE is an innovative mitral valve, intended for valve replacement of a native mitral valve through a minimally invasive implant procedure by means of a dedicated implant device. The EPYGON VALVE is a bio prosthesis, composed by a functional assembly of bovine pericardium on a NiTinol stent. The purpose of this trial is to assess the safety and feasibility of the Epygon™ Transcatheter mitral valve and the transapical delivery system, in adult patients with severe, symptomatic mitral regurgitation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Epygon™ Transcatheter Mitral Valve System | The EPYGON VALVE is an innovative mitral valve, intended for valve replacement of a native mitral valve through a minimally invasive implant procedure by means of a dedicated implant device. The EPYGON VALVE is a bio prosthesis, composed by a functional assembly of bovine pericardium on a NiTinol stent. |
Timeline
- Start date
- 2021-02-01
- Primary completion
- 2024-10-31
- Completion
- 2029-12-31
- First posted
- 2021-03-01
- Last updated
- 2023-08-07
Locations
10 sites across 4 countries: Austria, Italy, Serbia, Spain
Source: ClinicalTrials.gov record NCT04775108. Inclusion in this directory is not an endorsement.