The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants.
LVADs are efficacious in improving survival and functional status when used as a bridge to transplantation. The purpose of this study is to evaluate the safety and effectiveness of the VentrAssist LVAD in providing circulatory support in individuals who are awaiting heart transplants. The VentrAssist LVAD is a centrifugal flow pump. Its small size and mechanical simplicity offers benefits not available with currently approved LVADs, including facilitating a more limited implantation procedure, which could reduce surgical morbidity and mortality.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.
Quality of life
Functional status
Neurocognitive function
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