BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 51 / 176

Lumax Technical Manual 43
Table 14: Six Minute Walk Distance
Distance
(meters)
Study Control
Baseline
N
Mean
±
SE
Range
Median
127
283.14
±
9.27
23 to 511
302.00
61
269.43
±
13.77
29 to 507
244.00
Six-Month
N
Mean
±
SE
Range
Median
93
329.73
±
10.82
78 to 596
335.00
44
310.70
±
15.49
91 to 489
313.00
* Student's t-test, 2-sided
There are no clinically relevant differences in the six minute
walk test results between the study and the control group.
5. The purpose of Secondary Endpoint 5 is to evaluate the
improvement in the patient’s NYHA classification. Table 15
summarizes the average improvement in NYHA from
Baseline to Six-Months for 140 patients that were able to
complete both NYHA classification evaluations.
Table 15: Improvement in NYHA Classification at Six-Months
from Baseline
NYHA Change During OPTION Study
Change in NYHA
Class
Study Patients
(N=97)
(percentage)
Control Patients
(N=43)
(percentage)
Improved 2 classes 10 (10.3%) 2 (4.7%)
Improved 1 class 47 (48.5%) 20 (46.5%)
Total improved 57 (58.8%) 23 (51.2%)
No change
39 (40.2%) 20 (46.5%)
Worsened 1 class
1 (1.0%) 1 (2.3%)