Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120276
Status:
COMPLETED
Last Update Posted:
2009-05-07
First Post:
2005-07-07
Brief Title:
RESTOR-MV Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve
Sponsor:
Myocor
Organization:
Myocor
Study Overview
Official Title:
Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve RESTOR-MV
Status:
COMPLETED
Status Verified Date:
2008-05
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 purpose of this prospective randomized multi-center pivotal trial is to compare the safety and effectiveness of the off-pump closed heart Coapsys System Myocor Inc to open surgical repair of the mitral valve using an annuloplasty ring or band in patients with moderate to severe functional mitral regurgitation
Detailed Description:
Patient clinical evaluations will consist of 3-month 6-month and 12-month follow up of the primary endpoints Additional follow up of 18-month 24-month and annually thereafter will also be included
Study Oversight
Has Oversight DMC:
None
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?:
None