User Manual Part 4

CLINICAL STUDY - C ONTAK CD
D-19
Tab le D-11. Change in NYHA Class (continued)
All Patients
NYHA Class III/IV
CRT
(N = 109)
No CRT
(N = 116)
CRT
(N = 45)
No CRT
(N = 48)
Change in NYHA Class
N
%
N
%
P-value
a
N
%
N
%
P-value
a
Worsen 1 Class
13 11 .9 19 16.4 2 4.4 4 8.3
Worsen2orMoreClasses
10.910.9 00.000.0
a. P-value was calculated from Mantel-Haenszel test and reflects the between-group differences with respect to baseline.
Echocardiography––several echocardiography (echo) variables were
identified to assist in measuring the possible hemodynamic impact of CRT
(Table D-12 on page D-19). The limitation of this data is that patients
are measured while at rest, and therefore , the d ata may not r eflect any
hemodynamic benefit that m ay be observed when patients are exercising and
performing their daily activities.
Tab le D-12. Echocardiography results
CRT No CRT Between Groups
Parameter Timepoint
N
Mean ± SE
N
Mean ± SE Mean ± SE
P-value
All Patients
LVIDd (mm)
Post-recovery
Visit
228 70.4 ± 0.5 219 70.4 ± 0.5 0
––
Change at 6
Months
228 -3.4 ± 0.6 219 -0.3 ± 0.6 -3.1 ± 0.9 < 0.001
LVIDs (mm)
Post-recovery
Visit
228 58.3 ± 0.5 219 58.3 ± 0.5 0
––
Change at 6
Months
228 -4.0 ± 0.7 219 -0.7 ± 0.7 -3.3 ± 0.9 < 0.001
LVEF (%)
Post-recovery
Visit
222 27.8 ± 0.3 216 27.8 ± 0.3 0
––
Change at 6
Month
222 5.1 ± 0.7 216 2.8 ± 0.7 2.4 ± 1.0 0.020
NYHA Class III/IV
LVIDd (mm)
Post-recovery
Visit
104 71.2 ± 0.7 92 71.2 ± 0.7 0
––
Change at 6
Months
104 -4.9 ± 1.0 92 -0.2 ± 1.1 -4.7 ± 1.5 0.001
LVIDs (mm)
Post-recovery
Visit
104 59.2 ± 0.7 92 59.2 ± 0.7 0
––
- DRAFT -