Ignite Creation Date:
2024-05-06 @ 10:21 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03230747
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2017-07-24
Brief Title:
SAPIEN M3 EFS Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
Sponsor:
Edwards Lifesciences
Organization:
Edwards Lifesciences
Study Overview
Official Title:
Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
SAPIEN M3 EFS
Brief Summary:
This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System
Detailed Description:
Prospective single-arm multicenter early feasibility study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None