Ignite Creation Date:
2024-05-05 @ 11:03 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01242891
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2012-03-06
First Post:
2010-11-16
Brief Title:
Assess Safety and Probable Benefit of the EXCOR Pediatric Ventricular Assist Device Under a Continued Access Protocol
Sponsor:
Berlin Heart Inc
Organization:
Berlin Heart Inc
Study Overview
Official Title:
A Prospective Multi-center Single Arm Study to Assess the Safety and Probable Benefit of the Berlin Heart EXCOR Pediatric Ventricular Assist Device EXCOR PediatricUnder a Continued Access Protocol
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAP
Brief Summary:
The main purpose of this protocol is to provide a mechanism for continued access for patients that would have been enrolled into the primary cohorts of the IDE study
Detailed Description:
The data collection and protocols for this study remain consistent with the main IDE study for the EXCOR Pediatric Ventricular Assist Device This protocol was closed at the same time as the main IDE study due to FDA approval December 16 2011
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