Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04219618
Status:
TERMINATED
Last Update Posted:
2022-06-27
First Post:
2019-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Left Ventricular Assist Device (LVAD) Off or On Pump Implantation Study
Sponsor:
The University of Texas Health Science Center, Houston
Organization:
Study Overview
Official Title:
The Left Ventricular Assist Device Off or On Pump Implantation Study: A Single-center Randomized Trial (LVAD-ON-OFF)
Status:
TERMINATED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped because the manufacturer stopped producing the HeartWare LVAD device.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LVAD-ON-OFF
Brief Summary:
The purpose of this study is to compare adverse events after off-pump LVAD surgery or on-pump LVAD surgery.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: