Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04820764
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2021-03-25
Brief Title:
EFS of the CardioMech MVRS
Sponsor:
CardioMech AS
Organization:
CardioMech AS
Study Overview
Official Title:
Early Feasibility Study of the CardioMech Mitral Valve Repair System MVRS
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Safety and performance evaluation of the CardioMech Mitral Valve Repair System MVRS in patients with degenerative mitral valve regurgitation
Detailed Description:
The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System MVRS in patients diagnosed with moderate to severe 3 or severe 4 symptomatic degenerative mitral regurgitation and who are determined to be at intermediate or high surgical risk for mitral valve repair as assessed by the sites multidisciplinary heart team
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None