User Manual Part 4

C-16
CLINICAL STUD Y - DECREASE HF
The mean perce ntage of appropriately pace d be a ts du rin g a ctivities of daily
living was 99.5 ± 1.3 with a median of 100.0% (p <0.01) (Table C-12 on page
C-16).
Table C-12. Continuou s appropriate pacing during activities of daily living
Statistic
a
Result
N 69
Mean ± SD
99.5 ± 1 .3
Median 100.0
Range 93.1 - 100.0
P-value
b
<0.01
a. All patients in the Holter Substudy; N=69.
b. P-value calculated from a signed-rank test.
Continuous Appropriate Pacing During Exercise––The safety of CRT
therapy provided b y the investigational system was assessed by the percent
of time a patient receives appropriate pacing during the patient’s three-month
CPX test, as recorded with a Holter monitor. The appropriateness of CRT
delivery is defined by whether or not the device delivers CRT in accordance
with the physician’s programming. The objective of this endpoint was to
demonstrate that patients receive continuous appropriate pacing from the
device during exercise.
It is expected that patients will receive pacing approximately 95% of the time on
average. The null hypothesis was to be rejected if the lower one-sided 95%
confidence bound of the mean time paced were greater than 90%. Due to the
non-normality of the data, a non-parametric test of the median was performed
comparing the median to 90% instead of comparing the lower 95% confidence
bound to 90%.
The mean pe r ce ntage of appropriately paced b e at s during exercise was 99.4 ±
1.9 with a median of 100.0% (p < 0.01) (Table C-13 on page C-16).
Tab le C-13. Continuous a pp ropriate pacing during exercise
Statistic
a
Result
N 67
Mean ± SD
99.4 ± 1.9
Median 100.0
- DRAFT -