User Manual Part 4

D-16
CLINICAL STU DY - CONTAK CD
Table D-8. Change in Peak VO2 (continued)
All Patients
NYHA Class III/IV
Peak VO
2
(ml/kg/min)
CRT
(N = 216)
No CRT
(N = 201)
P-value
a
CRT
(N = 96)
No CRT
(N = 80)
P-value
a
3 Months 14.3 ± 0.2 13.9 ± 0.2 0.206 12.8 ± 0.4 12.1 ± 0.4 0.084
6 Months 14.4 ± 0.3 13.6 ± 0.3 0.030 13.8 ± 0.5 12.0 ± 0.5 0.003
a. P-values reflect the between-group differences with respect to baseline.
Six-Minute Walk––the Six-Minute Walk test is a measure of a patient’s ab ility
to sustain exercise during an activity simila r to that which a patient may typically
perform on a daily basis. For this test, patients are instructed to walk as far
as possible in 6 minutes in a level corridor. Figure D -4 on page D-16 and
Table D-9 on page D-16 provide the change in Six-Minute Walk.
375
325
275
350
250
Time (months)
Six Minute Walk Distance (m)
06
All Patients
∆ = 21 ± 10
p = 0.043
Mean ± SE
CRT (n = 224)
No CRT (n = 220)
Time (months)
06
NYHA Class III/IV
∆ = 39 ± 18
p = 0.029
CRT (n = 99)
No CRT (n = 90)
300
Figure D-4. Change in Six-Minute Walk
Table D -9. Change in Six-Minute Walk
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
Post-recove ry Visit 317 ± 5 317 ± 5
––
268 ± 9 268 ± 9
––
- DRAFT -