Ignite Creation Date:
2024-05-06 @ 8:36 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02771275
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2016-04-20
Brief Title:
Safety and Early Feasibility Study of the Harpoon Medical Device EFS
Sponsor:
Edwards Lifesciences
Organization:
Edwards Lifesciences
Study Overview
Official Title:
Safety and Performance Study of the Harpoon Medical Transapical Suturing Device TSD-5 in Subjects With Degenerative Mitral Regurgitation - EFSCE Mark Study for the Harpoon Medical Device in Poland
Status:
COMPLETED
Status Verified Date:
2024-01
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:
EFS
Brief Summary:
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5 The Harpoon device will provide many significant advantages over current surgical interventions including 1 a small minimally invasive incision 2 no sternotomy 3 no cardiopulmonary bypass 4 no aortic manipulation 5 a direct path to the valve plane 6 performed on a beating heart 7 real-time TEE-guided chordal length adjustment and 8 less complicated procedure that is teachable and adoptable
Detailed Description:
The TSD-5 is intended to secure ePTFE sutures on the mitral valve for the treatment of mitral valve disease
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?:
True
Is an FDA AA801 Violation?:
None