User Manual

52 Lumax Technical Manual
 Presence of another life-threatening, underlying illness
separate from their cardiac disorder.
1.6.3.3 Summary of Clinical Results
The
study involved 122 patients (96 males, 78.7%, and 26
females, 21.3%), with a mean age of 67.1 years (range: 35-87).
The cumulative enrollment duration is 621.3 months with mean
enrollment duration of 5.1 months. The patient follow-up
compliance rate for all enrolled patients is 98.5% (394 of 400
required follow-ups).
1.6.3.3.1 Primary Endpoint 1: Effectiveness of the V-V Delay
Feature
The primary endpoint was intended
to detect whether V-V
programmability and optimization contributed to significantly more
patients with “worsened” HF. Worsened was defined as:
 For 6MW, reduction of 35 meters distance on 6MW
during CRT with V-V programmability and optimization
compared to during CRT without V-V programmability
and optimization
 For QOL score, increase of 10 points in QOL score by
MLWHFQ during CRT with V-V programmability and
optimization compared to during CRT without V-V
programmability and optimization
 For each patient, i.e. as a responder’s analysis, the
occurrence of either worsened 6MW or QOL score during
CRT with V-V programmability and optimization.
Table 19
presents the mean 6-minute walk test distances and
QOL scores for Group 1 and Group 2 patients at the baseline, 1-
month and 2-month follow-ups. Table 19
reports unpaired patient
data for information purposes, with the primary endpoint analysis
utilizing paired data from the 1-month and 2-month follow-ups.