User Manual Part 4

CLINICAL STUDY - DECREASE HF
C-9
46
54
58
LVESD (mm)
50
Baseline 3-Month 6-Month
LV Offset BiV-CRT
All patients with data at a minimum of one visit, N=205
56
52
48
Figure C-4. Improvement in LVESD at Six Months
Tab le C-5. Improvement in LVESD at six months
Statistic LV Offset BiV-CRT
N
a
Estimate ± SE
N
a
Estimate ± SE
Baseline 104 55.7 ± 0.5 100 55.7 ± 0.5
3 Months 97 50.5 ± 0.9 97 48.9 ± 0 .9
6 Months 92 50.3 ± 0.9 91 47.1 ± 0 .9
Improvement at 6 Months -5.4 ± 0.7 -8.7 ± 0.7
Confidence Interval Upper Bound
-4.2
-7.5
a. N refers to the number of patients with paired data.
Qualit y of Life (QOL)––The effect of CRT on the patient’s perceived quality
of life was assessed using six-month change in QOL score. The Minnesota
Living with Heart Failure Questionnaire‚ was administered prior to implant and
subsequently at the three-month and six-month visits. A longitudinal analysis
that included all patients with data at a minimum of one visit was performed to
estimate six-month change from baseline in each group.
Both arms showed a statistic ally significant an d clinically meaningful
improvement (≤ -10 points) in QOL, an endpoint considered clinically
meaningful in previous randomized controlled trials of CRT (Figure C-5 on page
C-10, Table C-6 on page C-10). The null hypothesis was to be rejected if the
- DRAFT -