User Manual Part 4

CLINICAL STUDY - C ONTAK CD
D-13
Table D- 4. Pre-implant history (continued)
All Patients
NYHA Class III/IV
Characteristic
CRT
(N = 248)
No CRT
(N = 253)
P-value
a
CRT
(N = 117)
No C RT
(N = 110)
P-value
a
Arrhythmia/Conduction
Disorder [N (%)]
LBBB 133
(53.6)
138
(54.5)
0.83
59 (50.4) 59 (53.6)
0.55
RBBB
35 (14.1) 31 (12.3) 21 (17.9) 14 (12.7)
Non-Specific 80 (32.3) 84 (33.2) 37 (31.6) 37 (33.6)
Etiology [N (%)]
Ischemic 167
(67.3)
178
(70.4)
0.47
76 (65.0) 78 (70.9)
0.34
Non-Ischemic
81 (32.7) 75 (29.6) 41 (35.0) 32 (29.1)
a. P-values were calculated with Pearson’s chi-squared test.
CRT Effectiveness
Heart Failure Progression (Composite Index)––the Composite Index
(primary endpoint) was a combination of three events: all-cause mortality,
hospitalization for heart failure, and VT/VF event requiring therapy (Table D-5
on page D-13). A committee consisting of three heart failure specialists and
an electrophysiologist reviewed and adjudicated all patient deaths and all
hospitalizations, defined as an admission greater than 23 hours. Outpatient
care, emergency room care, and clinic visits less than 23 hours were collected
but not considered to be hospitalizations for the purposes of analysis.
Tab le D-5. Heart Failure Progression (Compo site Index)
CRT No CRT
Group
a
Heart F ailure M ortality
or Morbidity Event
N
%
N
%
Relative Reduction
with CRT
All Patients
(N = 490 )
Death from any cause
114.5166.5
15% p = 0.35
HF hospitalization 32 13.1 39 15.9
VT/VF
36 14.7 39 15.9
NYHA Class III/IV
(N = 227 )
Death from any cause
11 9.4 11 10.0
22% p = 0.23
HF hospitalization 23 19.7 27 24.5
VT/VF
21 17.9 22 20.0
a. All patients implanted and active 31 days post-implant.
Tw enty-seven patients died during the therapy phase. Mortality stratified by
treatment group and cause, as adjudicated by the Events Committee, is shown
- DRAFT -