Clinical Trials

U.S. FDA approves large reduction in size of WorldHeart RELIANT clinical trial design

Published in Medical Letter on the CDC and FDA, May 24th, 2006

World Heart Corporation (WHRT; WHT) (WorldHeart), announced that the U.S. Food and Drug Administration has given conditional approval of the company's Investigational Device Exemption (IDE) Supplement for modifications to the RELIANT (Randomized Evaluation of the Novacor LVAS In A Non-Transplant Population) clinical trial design.

The trial design changes include:

- Sample size reduction, from 390 to 208 patients. This reduction in patient enrollment is expected to significantly reduce the time required to complete the trial. The RELIANT Destination Therapy trial has already enrolled nearly 20% of the newly required number. The rate of patient...

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Source: Medical Letter on the CDC and FDA (2006-05-24)

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