User Manual

58 Lumax Technical Manual
Clinical Events Committee
The Clinical Events Committee (CEC) is an advisory review board
comprised of three physicians that are not participating in the
TRUST Study who reviewed and adjudicated all deaths, strokes,
surgical interventions, and cardiac adverse events that occur
during the study. The CEC also reviewed all divergent
classifications of actionable vs. non-actionable office follow up
visits between the physician and BIOTRONIK, and reviewed a
random sampling of 1% of office follow up visits in which there is
no disputed classification.
1.6.4.3 Summary of Clinical Results
The study involved
1443 patients (1038 males, 71.9%), with a
mean age of 63.5 years (range: 20-95). The cumulative
enrollment duration is 18,367 months with mean enrollment
duration of 12.7 months. The patient follow-up compliance rate for
all enrolled patients is 87.5% in Group 1 and 78.8% in Group 2.
1.6.4.3.1 Primary Endpoint 1: Home Monitoring
Effectiv
eness
The purpose of primary endpoint 1 (HM efficacy) was to compare
the number of in-office ICD follow-ups for patients in Group 1
(HM) to the conventional, calendar-based method of ICD
follow-up as in Group 2 (Control).
Detailed primary endpoint 1 results are presented in Table 21
.
Table 21: Primary Endpoint Group 1 vs. Group 2
Office Follow-up Visits
No. of
Pts**
Scheduled Unscheduled Total
Group 1
(HM)
898
n = 991
1.3 ± 1.0 per pt yr
13.1% actionable
n = 401
0.6 ± 1.7 per pt yr
29.7% actionable
1.9 ± 1.9
per pt yr
Group 2
(Control)
414
n = 1110
3.0 ± 1.1 per pt yr
10.7% actionable
n = 117
0.4 ± 1.4 per pt yr
29.1% actionable
3.4 ± 1.7
per pt yr
p value < 0.001 0.032
< 0.001
* Up to and including 12 month follow-up data
** Number of patients that have contributed at least 1 follow-up