Cardiomyopathies Clinical Trial
Official title:
Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Pivotal Trial
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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