User Manual Part 4

C-14
CLINICAL STUD Y - DECREASE HF
Months from Randomization Visit
Percent Free from HF AE
All patients implanted and active at the randomization follow-up; N=338.
40
50
60
70
80
90
100
N
Acceptance Boundary
338 313 300 290 279 267 258
0123456
Event-Free Rate
Lower One-Sided 95% Confidence Bound
Figure C-7. Time to Heart Failu re Related Adverse Event
Device Safety
Primary Endpoint
System-Related Complication Free Rate––The safety of the investigational
system was assessed by the system related complication free rate observed
in the period between implant and six months post-implant in all patients
attempted or implanted. System related complication free rate is defined
as the proportion of patients without a system related complication w ithin
six months post-implant. All patients who underwent an implant procedure
were included in the analysis. Table C-11 on page C-14 shows the system
related complication free rates by event type. A Kaplan-Meier analysis is also
presented in (Figure C-8 on page C-15) to show time to events.
Table C-11. System-related complication free rate at six months
Complication
a
Number
ofEvents
Number
of Patients
Complication
Free Rate
Lower One-Side d
95% Confidence
Bound
LV Lead 35 31 91.3 88.5
RA Lead 11 9 97.5 95.7
RV Lead 3 3 99.2 97.8
PG
14 14 96.1 94 .0
Procedure 17 16 95.5 93 .3
Tota l
b
80 60 83.2 79 .7
a. All patients implanted or attempted; N=358.
b. Includes patients in the Safety Arm.
- DRAFT -