BIOTRONIK Evia DR, Technical Manual

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Evia Technical Manual 37
6.3.1.3 Results
Primary Endpoint: Effectiveness of the CLS Algorithm during
Emotional Stressors
H
o
: The average observed sensor driven peak heart rate
during emotional stress testing does not significantly exceed
the average observed resting heart rate for the tested patient
population.
H
a
: The average observed sensor driven peak heart rate
during emotional stress testing significantly exceeds the
average observed resting heart rate for the tested patient
population.
As shown in
Figure 3
, for these 40 subjects, the average heart
rate increased from 64.27 ± 4.8 bpm to 71.26 ± 5.4 bpm when
the pacemaker was programmed to an accelerometer pacing
mode during the ER Test
©
. For the same test, the average heart
rate increased from 65.24 ± 4.0 bpm to 83.90 ± 7.5 bpm when
the pacemaker was programmed to the CLS pacing mode.
Figure 3: Average Heart Rates at Baseline and during ER
Test©
Peak Heart Rates (n=40)
83.9
71.2
65.2
64.2
50
60
70
80
90
10
Restin ER Test
©
CL
R