Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure

The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death. The primary endpoint is survival at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. Patient must survive 60 days post-explant for recovery to be considered successful. Secondary endpoints include:

• Overall survival
• Incidence of all serious adverse events, neurocognitive status and unanticipated adverse device effects.
• Incidence of all device failures and device malfunctions
• Quality of Life improvement, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQoL EQ-5D
• Functional status improvement, as measured by the New York Heart Association (NYHA) and 6-minute walk

The HeartWare® LVAD System was approved by the US FDA on November 20, 2012 as a bridge to cardiac transplantation (reference PMA P100047). Patients enrolled into this study will be followed to an outcome at six months, and then patients will receive continued follow-up in a separate study.