RANDOMIZED EVALUATION OF MECHANICAL ASSISTANCE FOR CONGESTIVE HEART FAILURE

$0M01FY2000RRNIH

University Of Minnesota Twin Cities, Minneapolis MN

Investigators

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Abstract

This is a multicenter, randomized clinical trail to evaluate the efficacy, safety and cost-effectiveness of a left ventricular assist device in the treatment of heart failure. Ten patients at the University of Minnesota with end-stage congestive heart failure will be randomized to either standard medical therapy (n=5) or a mechanical left ventricular assist device (n=5) and followed for two years. The primary end point is patient survival. Secondary end points are the quality of life, hospitalization, and cost. Patients assigned to treatment with the mechanical left ventricular assist device will convalesce in the GCRC. Patients in both groups will be followed at monthly intervals as GCRC outpatients.

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