ASAIO Journal · 1995 · 12 citations · 0 references
MedicineCardiologyAssistive TechnologyCardiothoracic SurgeryClinical CardiologyCardiopulmonary BypassExtracorporeal CirculationHeart FailureHemodynamic SupportMechanical Circulatory SupportClinical Endpoint EvaluationClinical Evaluation StandardsLeft Ventricular Assist Device TherapyLeft Ventricular Assist DevicesRefractory Heart Failure
In this summary, the authors provide the background of and proposed protocol for a clinical evaluation of the safety and efficacy of the Novacor N120 Left Ventricular Assist System, sponsored by the National Heart, Lung, and Blood Institute. Although the clinical trial was never carried out, the protocol developed for this trial may be useful to other investigators considering a clinical trial of a circulatory support device. The protocol is summarized here and in five more detailed articles in this issue.