Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483197
Status:
UNKNOWN
Last Update Posted:
2009-09-09
First Post:
2007-06-04
Brief Title:
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial
Sponsor:
Ventracor
Organization:
Ventracor
Study Overview
Official Title:
Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Pivotal Trial
Status:
UNKNOWN
Status Verified Date:
2009-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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 study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants
Detailed Description:
LVADs are efficacious in improving survival and functional status when used as a bridge to transplantation The purpose of this study is to evaluate the safety and effectiveness of the VentrAssist LVAD in providing circulatory support in individuals who are awaiting heart transplants
The VentrAssist LVAD is a centrifugal flow pump Its small size and mechanical simplicity offers benefits not available with currently approved LVADs including facilitating a more limited implantation procedure which could reduce surgical morbidity and mortality
The VentrAssist LVAD is a centrifugal flow pump Its small size and mechanical simplicity offers benefits not available with currently approved LVADs including facilitating a more limited implantation procedure which could reduce surgical morbidity and mortality
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