User Manual Part 4

CLINICAL STUDY - CONTAK RENEWA L
E-7
Pacing During Exercise
The mean percentage of appropriately continuously paced beats during
exercise was calculated as 98.3 ± 5.6% with a m edian of 100% and is
summarized in Table E-6 on page E-7. Continuous appropriate BiV pacing
is defined as pacing provided between the lower rate limit and the MTR,
excluding PVC s.
Table E-6. Exercise: continuous appropriate BiV pacing
Statistic
P-value
Mean ± SD
98.3 ± 5.6
–
Range 68.1 – 100
–
Median 100 <0.01
Device Counters
Finally, during the study CONTAK RENEWAL device counters were found
to correlate highly to the data collected on the independent Holter monitors
(Table E-7 on page E-7).
Table E-7. Correlation between holter and device
Mean ± SD Correlation (P-value)
Holter 97,536 ± 13,307
0.97 (<0.01)
Device 100,143 ± 13,373
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- DRAFT -