User Manual Part 4

B-36
CLINICAL STU DY - COMPANION
25
10
5
20
0
Time (months)
∆ Quality of Life Score (points)
3 6
CRT
OPT
∆ = 17 ∆ = 13
Mean ± SE
15
30
Figure B-16. Quality of Life score
TableB-14. QualityofLifescore
CRT OPT
Quality of Life
(points)
N
Mean ± S.E. (95% CI)
N
Mean ± S.E. (95% CI)
P-value
a
Change at 3 months
289
23 ± 1 (20.1, 25.7)
72
6±3(0.6,11.3)
< 0.001
Change at 6 months
279
23 ± 1 (19.7, 25.4)
66
10 ± 3 (4.2, 15.2)
< 0.001
a. P-values are not adjusted for multiplicity and were obtained using one-tailed longitudinal analysis methods.
Additional Functional Capacity Data
In addition to the Exercise Performance sub-study, functional capacity was
evaluated by means of NYHA Class, six-minute walk distance, and Minnesota
Living with Heart Failure Questionnaire QOL for the all patients randomized
to OPT and CRT-D through 6-months of follow up.
NYHA Class, six-minute walk distance, and QOL scores were significantly
improved in the CRT-D group compared to the OPT group at 3 and 6 months
(Table B-15 on page B-36). These findings are similar to those presented in
the exercise performance sub-study and previous cardiac resynchronization
therapy trials.
Table B-15. Changes in six-minute walk, QOL, and NYHA
CRT-D OPT
P-value
a
Six Minute Walk Distance
N
Mean ± SD
N
Mean ± SD
Change at 3 months
420 42 ± 98 172 8 ± 82 < 0.0001
- DRAFT -