User Manual

26 Lumax Technical Manual
There have been 4 patient deaths reported for the control group
(out of 67 total control patients) and 10 patient deaths have been
reported for the study group (out of 133 total study patients).
None of the deaths were related to the implanted CRT-D system.
One patient in the control group died prior to receiving a
biventricular device implant. There is no significant difference
between the number of deaths in the study group versus the
control group (p = 0.777, Fisher's Exact Test, 2 sided). Table 6
provides a summary of reported patient deaths and Table 7
provides survival percentages by follow-up interval during the first
12 months of study participation.
Table 6: Summary of Patient Deaths
Study
(N = 133)
Control
(N = 67)
Category of
Death
Number of Patients Number of Patients
Sudden Cardiac 1 1
Non-Sudden
Cardiac
5 2
Non-Cardiac 4 1
All Causes
10 4
Figure 3 shows the associated Kaplan-Meier survival curves for
the study and control group. The significance level for the
difference between the two study groups based on a Log Rank
test was p = 0.795.