BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 45 / 176

Lumax Technical Manual 37
Table 8: Complications at 6-Month – Study and Control
Study versus Control
Comparison
Category
Study
N = 133
Control
N = 67
Delta 95% CI P-value
Procedure
Related 6 (4.51%) 1
(1.49%)
3.02
%
[-3.64%,
8.45%]
0.428
Atrial Lead
Related 3 (2.26%) 1
(1.49%)
0.76
%
[-5.74%,
5.37%]
1.000
ICD Lead
Related 3 (2.26%) 0 (0%) 2.26
%
[-3.03%,
6.53%]
0.552
LV Lead
Related 26
(19.55%)
9
(13.43%)
6.12
%
[-5.50%,
16.45%]
0.329
Device
Related
7 (5.26%) 5
(7.46%)
-
2.20
%
[-11.42%,
4.77%]
0.541
Other
Medical
Related 9 (6.77%) 2
(2.99%)
3.78
%
[-3.82%,
10.13%]
0.341
Total
Procedure,
Lead and
Device
Related
39
(29.32%)
15
(22.39%)
6.94
%
[-6.46%,
19.17%]
0.317
Total
46
(34.59%)
17
(25.37%)
9.21
%
[-4.96%,
21.99%]
0.201
1.6.2.7 Primary Safety Enpoint Analysis and Conclusions
The observed procedure, lead and device related complication-
free rate at 6 months was 70.68%. The 95% confidence interval
for the complication-free rate was [62.16%, 78.25%]. The lower,
one-sided 95% confidence bound for the complication-free rate
was 63.50%. Therefore the procedure, lead and device related
complication-free rate at 6 months did not meet the pre-specified
acceptance criterion for this endpoint.