User Manual Part 4

CLINICAL STUDY - C ONTAK CD
D-17
Table D-9. Change in Six-Minute Walk (continued)
All Patients
NYHA Class III/IV
SixMinuteWalkDistance(meters)
CRT
(N = 224)
No CRT
(N = 200)
P-value
a
CRT
(N = 99)
No C RT
(N = 90)
P-value
a
3 Months 348 ± 7 331 ± 8 0.058 312 ± 12 280 ± 12 0.028
6 Months 353 ± 8 332 ± 8 0.043 327 ± 14 288 ± 15 0.029
a. P-values reflect the between-group differences with respect to baseline.
Quality o f Life (QOL)––QOL was assessed using the 21-question Minnesota
Living with Heart F ailure Questionnaire
®
. Each question is answered by the
patient, ranking each item on a scale ranging from 0 to 5. A lower total score
indicates an improved quality of life. Figure D-5 on page D-17 and Table D-10
on page D-17 provide the change in QOL.
30
40
50
35
55
Time (months)
QOL Score (points)
06
All Patients
∆ = -2.1 ± 2.4
p = 0.40
Mean ± SE
CRT (n = 234)
No CRT (n = 225)
Time (months)
06
NYHA Class III/IV
∆ = -10.1 ± 4.2
p = 0.017
CRT (n = 107)
No CRT (n = 96)
45
Figure D-5. Change in Quality of Life
Table D-10. Change in Quali ty of Life
All Patients
NYHA Class III/IV
QOL (points)
CRT
(N = 234)
No CRT
(N = 225)
P-value
a
CRT
(N = 107)
No C RT
(N = 96)
P-value
a
Post-recovery Visit 41.8 ± 1.1 41.8 ± 1.1
––
52.7 ± 1.5 52.7 ± 1.5
––
- DRAFT -