Heart Failure, Congestive Clinical Trial
Official title:
The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy
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).
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. ;
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