Use Instructions

56
Table 13: Baseline Characteristics: ITT Population
FIX-HF-5C2
FIX-HF-5C
Variable
OPTIMIZER
OPTIMIZER
P-value
1
Control
P-value
1
Age (yrs)
66.3 ± 8.9 (60)
63.1 ± 10.9 (74)
0.071
62.8 ± 11.4 (86)
0.049
Male
53 (88.3%)
54 (73.0%)
0.032
68 (79.1%)
0.182
Ethnicity (White)
40 (66.7%)
55 (74.3%)
0.346
61 (70.9%)
0.590
CHF Etiology (Ischemic)
41 (68.3%)
46 (62.2%)
0.473
51 (59.3%)
0.299
Prior MI
36 (60.0%)
36 (48.6%)
0.224
51 (59.3%)
1.000
Prior CABG
13 (21.7%)
18 (24.3%)
0.837
23 (26.7%)
0.560
Prior ICD or PM System
55 (91.7%)
67 (94.4%)
0.731
73 (85.9%)
0.432
Prior ICD (ICD,CRT-D,S-ICD)
53 (88.3%)
66 (93.0%)
0.382
73 (85.9%)
0.804
Prior PM
2 (3.3%)
1 (1.4%)
0.593
0 (0.0%)
0.170
Angina
2 (3.3%)
5 (6.8%)
0.459
6 (7.0%)
0.471
Diabetes
18 (30.0%)
38 (51.4%)
0.014
42 (48.8%)
0.027
Baseline Permanent Atrial Fibrillation
9 (15.0%)
0 (0%)
0.0005
0 (0%)
0.0002
History of Atrial Arrhythmias
34 (56.7%)
25 (33.8%)
0.009
35 (40.7%)
0.065
Atrial Flutter
5 (8.3%)
8 (10.8%)
0.772
6 (7.0%)
0.761
Atrial Fibrillation
28 (46.7%)
20 (27.0%)
0.029
27 (31.4%)
0.082
Frequent PACs
3 (5.0%)
3 (4.1%)
1.000
1 (1.2%)
0.306
Other Atrial Abnormalities
2 (3.3%)
2 (2.7%)
1.000
3 (3.5%)
1.000
History of Ventricular Arrhythmias
17 (28.3%)
26 (35.1%)
0.459
28 (32.6%)
0.716
Ventricle Fibrillation
5 (8.3%)
5 (6.8%)
0.752
8 (9.3%)
1.000
Ventricular Tachycardia
13 (21.7%)
19 (25.7%)
0.685
19 (22.1%)
1.000
Frequent PVCs
5 (8.3%)
8 (10.8%)
0.772
7 (8.1%)
1.000
NYHA
Class III
59 (98.3%)
64 (86.5%)
0.023
78 (90.7%)
0.082
Class IV
1 (1.7%)
10 (13.5%)
0.023
8 (9.3%)
0.082
1
Compared to FIX-HF-5C2 OPTIMIZER Group via Fishers exact test for binary variables and two-sample t-test for continuous variables.