Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-27 @ 11:11 AM
Study NCT ID:
NCT01001793
Status:
TERMINATED
Last Update Posted:
2011-12-23
First Post:
2009-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levacor™ Ventricular Assist Device (VAD) Bridge to Transplant Study
Sponsor:
World Heart Corporation
Organization:
Study Overview
Official Title:
Evaluation of the Levacor™ Ventricular Assist Device as a Bridge to Cardiac Transplantation
Status:
TERMINATED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Commercial considerations relating to required device modifications.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Levacor™ Ventricular Assist Device (VAD) has been designed for mechanical circulatory support in heart failure patients. The purpose of this clinical study is to determine its safety and efficacy as a bridge to transplant (BTT) in cardiac transplant candidates with presumed non-reversible left ventricular failure.
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?: