User Manual Part 4

CLINICAL STUDY - C ONTAK CD
D-11
Table D-3. Pre-implant assessment
All Patients
NYHA Class III/IV
Characteristic
CRT
(N = 248)
No CRT
(N = 253)
P-value
a
CRT
(N = 117)
No CRT
(N = 110)
P-value
a
Age at Implant
(years)
N 248 253 117 110
Mean ±
SD
66.0 ± 10.5 66.3 ± 10.5 0.73 66.1 ±
10.5
65.8 ± 10.5 0.80
Range 26.1 - 82.6 29.5 - 86.3 26.1 - 82.5 38.3 - 85.3
Gender [N (%)]
Male
210 (84.7) 211 (83.4)
0.70
90 (76.9) 86 (78.2)
0.82
Female
38 (15.3) 42 (16.6) 27 (23.1) 24 (21.8)
NYHA Class [N
(%)]
II
80 (32.3) 83 (32.8)
0.66
20 (17.1) 11 (10.0)
0.08
III
148 (59.7) 144 (56.9) 85 (72.6) 78 (70.9)
IV
20 (8.1) 26 (10.3) 12 (10.3) 21 (19.1)
Concomitant
Medications [N
(%)]
ACE or
ARB
212 (85.5) 224 (88.5)
0.31
95 (81.2) 98 (89.1)
0.10
Beta
Blocker
119 (48.0) 117 (46.2)
0.70
53 (45.3) 44 (40.0)
0.42
Digoxin
172 (69.4) 171 (67.6)
0.67
84 (71.8) 75 (68.2)
0.55
Diuretic
217 (87.5) 210 (83.0)
0.16
108 (92.3) 95 (86.4)
0.15
Qualifying LVEF
(%)
N 248 253 117 110
Mean ±
SD
21.4 ± 6.6 21.5 ± 6.7 0.74 20.6 ± 6.4 21.1 ± 6.2 0.61
Range 5.0 - 35.0 10.0 - 35. 0 8.0 - 35.0 10.0 - 35.0
PR Interval
b
(ms)
N 224 222 107 91
Mean ±
SD
205± 42 202 ± 49 0.44 204 ± 41 200 ± 5 4 0.60
Range 88 - 336 104 - 400 136 - 336 110 - 400
Qualifying QRS
Duration
b
(ms)
N 226 224 109 93
Mean ±
SD
160 ± 2 7 156 ± 26 0.06 164 ± 27 152 ± 2 4 < 0.01
Range 120 - 240 120 - 264 120 - 240 120 - 222
Resting Heart Rate
( bpm)
N 248 253 117 110
- DRAFT -