40 HVAD® Instructions for Use
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Appendix
Reference
Guides
Alarms and
Emergencies
Patient
Management
Surgical
Implant and
Explant
Monitor
Peripherals
and
Accessories
HVAD
®
Pump Overview
Introduction
1.9 Destination Therapy Supplemental Study (continued)
included all subjects who received a device. It was analyzed according to the device to which
the subjects were randomized.
All safety analyses were performed on the safety population (SAF), which assigned subjects to
the device they actually received. The SAF was equivalent to the mITT population.
The Complete Case Population includes all subjects in the mITT population except those who
withdraw, are lost to follow-up, or have missing outcomes (any subject with missing post-event
mRS) on original device. It differs for each objective. For the primary endpoint, the Complete
were lost to follow-up, and any subjects who were missing CEC adjudicated mRS scores (both
day of event and 24 weeks post-event) for the latest stroke event on original device. For the
secondary endpoint of stroke/TIA incidence at 12 months on the originally implanted HVAD,
withdrew or were lost to follow-up. For the secondary endpoint of stroke-free success (mRS < 4
population excluding subjects who withdrew or were lost to follow-up, and those subjects who
were missing a 24 week mRS score for their last stroke on original device (within 1 year post
original implant).
C. Study Population Demographics and Baseline Parameters
The demographics and baseline characteristics of the study population, as summarized in Table 18,
are typical for an LVAD study performed in the U.S. The baseline characteristics of the two
treatments at the time of enrollment.
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