Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121472
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2005-07-12
Brief Title:
Thoratec HeartMate II Left Ventricular Assist System LVAS for Bridge to Cardiac Transplantation
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
The HeartMate II LVAS Pivotal Study Protocol Bridge to Cardiac Transplantation
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 a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying
The HeartMate II LVAS was approved by the US FDA on April 21 2008 as a bridge to cardiac transplantation reference PMA P060040 It was approved for commercial distribution in Canada on May 20 2009 reference Medical Device Licence 79765 Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome
The HeartMate II LVAS was approved by the US FDA on April 21 2008 as a bridge to cardiac transplantation reference PMA P060040 It was approved for commercial distribution in Canada on May 20 2009 reference Medical Device Licence 79765 Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome
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 Patient outcomes will be compared to objective performance criteria based on historical data from other Thoratec implantable ventricular assist devices
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