Innovative Trial Design Could Reduce Time To Market
Sat, 17 Feb 2007 01:00 AM EST
... Destination Therapy (DT) TrialThe DT Protocol is a prospective, randomized, controlled trial with two modules. Both modules have event driven end points.Module A (primary) consists of 180 patients with 2:1 randomization of the VentrAssist to the control arm, which does not require implantation of an LVAD approved by the FDA for DT. [click link for full article] ...
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