Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04775108
Status:
RECRUITING
Last Update Posted:
2023-08-07
First Post:
2021-02-25
Brief Title:
First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon TRanscatheter Mitral VAlve System
Sponsor:
Epygon
Organization:
Affluent Medical
Study Overview
Official Title:
First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon TRanscatheter Mitral VAlve System MINERVA FIH
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None