Evaluation of an implantable ventricular assist system for humans with chronic refractory heart failure. Study overview. LVAS Study Group. Left Ventricular Assist System.
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.
Pennington
D G
DG
National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Griffith
B P
BP
McKinlay
S M
SM
Oyer
P E
PE
Domanski
M J
MJ
Portner
P M
PM
Watson
J T
JT
D002985:Clinical Protocols; D005500:Follow-Up Studies; D006333:Heart Failure / Q000628:therapy*; D006353:Heart-Assist Devices / Q000592:standards*; D006801:Humans; D007391:International Cooperation; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D018570:Risk Assessment