User Manual Part 4

G-4
CLINICAL STUDY - VITALITY
The VT/VF detect ion time of the VITALITY ICD was f ou nd to be with in two
seconds of the VENTA K PRIZM 2 detection time, leading to the conclusion that
activating the additional VITA LITY features does not have a negative effect on
the existin g ICD sensing and detection functionality (Ta ble G-2 on page G-4).
Table G-2. Acute stu dy results
Study Endpoint
VITALITY
(Mean ± std)
N
VENTAK
PRIZM 2 DR
(Mean ± std)
N
VT/VF Detection Time (seconds)
3.60 ± 0.60
N=47
3.52 ± .057
N=47
p-value: <0.001
- DRAFT -