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Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy

Heart Failure, Congestive Clinical Trial

Official title:
The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy

Clinical Trial 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 P060040/S005).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00121485
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase N/A
Start date February 2005
Completion date January 2012
View Details
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