Chronic Heart Failure Clinical Trial
Official title:
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.
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Status | Clinical Trial | Phase | |
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