Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-05 @ 3:46 AM
Study NCT ID:
NCT02803957
Status:
RECRUITING
Last Update Posted:
2019-12-05
First Post:
2016-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
Sponsor:
NeoChord
Organization:
Study Overview
Official Title:
Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair
Status:
RECRUITING
Status Verified Date:
2019-12
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:
ReChord
Brief Summary:
The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: