User Manual

54 Lumax Technical Manual
Table 20. QOL and 6-Minute Walk Responder Classification
(Effectiveness)
QOL
Group 1
(N = 56)
Group 2
(N = 52)
Total
(N = 108)
Worsened 9 (16.1%) 6 (11.5%) 15 (13.9%)
Not worsened 47 (83.9%) 46 (88.5%) 93 (86.1%)
6-Minute Walk (N = 56) (N = 51) (N = 107)
Worsened 14 (25.0%) 15 (29.4%) 29 (27.1%)
Not worsened 42 (75.0%) 36 (70.6%) 78 (72.9%)
Composite (N = 55) (N = 51) (N = 106)
Worsened 21 (38.2%) 18 (35.3%) 39 (36.8%)
Not worsened 34 (61.8%) 33 (64.7%) 67 (63.2%)
The estimate of the proportion of subjects who were classified as
“Not Worsened” was 63.2% (67/106). The lower, exact, one-sided
95% confidence bound for this observed proportion is 54.8%. The
difference between the performance goal of 63% and 54.8% is
8.2%. This is lower than the pre-specified clinically significant
difference () of 12%.
1.6.3.3.2 Primary Endpoint 2: Safety of the V-V Delay
Feature
The purpose of Primary Endpoint 2 is to evaluate adverse events
that require additional invasive
intervention to resolve, specifically
related to the V-V delay feature of the Lumax HF-T. These
adverse events include any software issues related to V-V delay
programming or any adverse event that occurs after V-V delay
optimization and that can be directly attributed to the use of the
V-V delay feature.
There have been 0 reported complications related to the V-V
delay feature for the 122 patients enrolled into the study.