22 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
1.8 US Clinical Study: Destination Therapy (continued)
B. Accountability of PMA Cohort
Pre-specified Interim Analysis
principal analysis cohort if the Control group success rate for the primary endpoint was at least
55%; as shown below, the observed success rate for the Control group was 59%. A total of 451
patients (inclusive of the initial 300 patients) were enrolled, of which 445 were implanted with a
analysis and full enrollment cohorts. FDA considered the interim analysis to be the principal
effectiveness of the HVAD. The analyses from the full enrollment cohort are included in the Other
Results section.
cohort (300 patients) had been followed through the 2-year primary endpoint time point. The
disposition of the patients is shown in Figure 4.
consented (Intent-to-Treat (ITT)) and then enrolled in the study.
The Anesthetized Population (AP) included all randomized subjects who receive induction of
anesthesia for implantation.
The Anesthetized and Implanted Population (AIP) population, equivalent to an As Treated
population, consisted of all randomized subjects who received induction of anesthesia for
crossed over from HVAD to Control and three (3) patients crossed over from Control to HVAD
after randomization but before receiving a device, and one (1) patient in the Control arm
did not receive any device. As such, the AT population for the interim analysis consists of 300
patients, 197 in the HVAD arm and 103 in the Control arm.
The Per Protocol (PP) population included all subjects in the AIP population analyzed according
The Inclusion Compliant (IC) population included all randomized subjects who received the
LVAD to which they were randomized and who did not violate certain inclusion and exclusion
criteria that would likely have an effect on outcome.
The primary analysis was performed on the Per Protocol (PP) population. All safety analyses were
performed on the AIP population.
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