Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-05 @ 2:07 PM
Study NCT ID:
NCT02607527
Status:
COMPLETED
Last Update Posted:
2024-10-24
First Post:
2015-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System
Status:
COMPLETED
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:
Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
Detailed Description:
Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
This trial is designed in accordance with the 2014 ACC/AHA guidelines for valvular heart disease, and the consensus statement of MVARC 2015.
Subjects will undergo transcatheter implantation of the Millipede IRIS implant.
This trial is designed in accordance with the 2014 ACC/AHA guidelines for valvular heart disease, and the consensus statement of MVARC 2015.
Subjects will undergo transcatheter implantation of the Millipede IRIS implant.
Study Oversight
Has Oversight DMC:
False
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?: