User Manual Part 4

C-4
CLINICAL STUD Y - DECREASE HF
• Were enrolled in any concurrent study, without Guidant written approval,
that may confound the results of this study
DEMOGRAPHIC DATA
Patient enrollm ent (Figure C-1 on page C-4) and baseline characteristics
(Table C-2 on page C-4) are detailed below.
Enrolled
360
Implant
342
Attempt
16
Death
1
Intent
2
Death
3
Received
Randomization
Assignment
325
Withdrawal
1
Incomplete
Baseline
Testing
13
Expert Ease
BiV Suggestion
19
Randomized
306
LV-CRT
101
LV Offset
104
BiV-CRT
101
Safety Arm
32
Figure C-1. DECREASE-HF Study Patient Enrollment and Randomization
Tab le C-2. DECREASE-HF study patient characteristics
Characteristic
Measurement
LV-CRT
(N=101)
LV Offset
(N=104)
BiV-CRT
(N=101)
P-value
a
Age at Implant (years)
N 101 104 101
Mean ± SD
67.4 ± 9.6 66.6 ± 10.5 66.2 ± 10.6 0.69
Range 45.4 - 87.3 32.4 - 85.6 40.6 - 86.2
Gender [N (%)]
Male
66 (6 5) 70 (67) 69 (68)
0.90
Female
35 (3 5) 34 (33) 32 (32)
NYHA Class [N (%)]
III
98 (9 7) 100 (96) 101 (100)
0.16
IV
3(3) 4(4) 0(0)
- DRAFT -