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Evaluation of an implantable ventricular assist system for humans with chronic refractory heart failure. Study
D G Pennington1, B P Griffith, S M McKinlay
1National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
ASAIO Journal (American Society for Artificial Internal Organs : 1992)
|January 1, 1995
Abstract:
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.