Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121485
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2005-07-12
Brief Title:
Thoratec HeartMate II Left Ventricular Assist System LVAS for Destination Therapy
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
The HeartMate II LVAS Pivotal Study Protocol Destination Therapy
Status:
COMPLETED
Status Verified Date:
2022-06
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:
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System LVAS as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation
The Destination Therapy indication for use was approved by FDA on January 20 2010 ref PMA P060040S005
The Destination Therapy indication for use was approved by FDA on January 20 2010 ref PMA P060040S005
Detailed Description:
The HeartMate II is a high speed electric axial flow rotary blood pump The pump drains blood from the left ventricular apex via a rigid inlet cannula and ejects into the aortic root via an outflow cannula joined to the aorta with an end to side anastomosis Power and control of the pump are delivered through a percutaneous cable from the pump to the belt-worn System Driver
The Destination Therapy trial is a prospective randomized unblinded non-inferiority evaluation of the HeartMate II LVAS compared to the HeartMate XVE
The Destination Therapy trial is a prospective randomized unblinded non-inferiority evaluation of the HeartMate II LVAS compared to the HeartMate XVE
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