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36 Lumax Technical Manual
1.6.2.5 Effectiveness Endpoint Analysis and Conclusions
A composite rate of six minute walk test and QOL improvement
from Baseline to the Six-Month follow-up is evaluated as a
measure of CRT effectiveness. For this analysis both six minute
walk test and QOL are equally weighted at 50%.
The mean difference in the composite rate between study and
control group was 20.53% with an associated one-sided, 95%
confidence bound is (-6.10%). The p-value for non-inferiority
within 10% is 0.030. The analysis of the composite rate in six
minute walk test distance and QOL score demonstrates that the
study group is non-inferior to the control group and that the
primary effectiveness endpoint was met (p=0.030).
1.6.2.6 Primary Endpoint 2: Complication-Free Rate
(Safety)
The purpose of Primary Endpoint 2 was to evaluate complications
(adverse events that require additional invasive intervention to
resolve) related to the implanted CRT system which includes the
Tupos LV/ATx, the right atrial lead, the right ventricular ICD lead,
the left ventricular lead, and the implant procedure. The target
complication-free rate at Six-Months is 85%.
Table 8 provides the categorized complication rates at 6-months
for the study and the control group as well as a comparison
between the study and the control group.