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Activity Number: 646
Type: Contributed
Date/Time: Thursday, August 8, 2013 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #309069
Title: Patient Year Method for Clinical Outcome in Left Ventricular Assist Device Trial
Author(s): Hong Wang*+ and Wei Xu and Kevin Najarian
Companies: HeartWare Inc and HeartWare and HeartWare
Keywords: Medical Devices ; LVAD ; statistical test ; Patient Year
Abstract:

The patient year method has been widely used in epidemiology. Recently the approach was applied to left Ventricular assist device (LVAD) trials and several papers were published in circulation: cardiovascular intenvention2 (AHA). We will use patient year approach to assess clinical outcomes in a LVAD bridge trial and test the event rate with several statistical methods to compare the difference among the methods. The LVAD bridge trial data will be used to demonstrate the difference of the approaches. A proposed statistical testing method will be explored for each method.


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