The device that necessitated the clinical trial by Thoratec Corporation, the sponsor, is the Left Ventricular Assist Device (LVAD). The device is meant to assist the left ventricle of the heart to perform its function of pumping blood to the aorta and onwards to vital organs of the body. The device is prescribed for patients whose hearts are not able to function optimally. The study type employed during the clinical trial of the device was observational, non-randomized, and controlled (St. Jude Medical). It took place in a number of HM II implanting centers. The observational model incorporated prospective and ...
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