User Manual Part 4

C-8
CLINICAL STUD Y - DECREASE HF
15
13
12
Peak VO
2
(ml/kg/min)
14
Baseline 3-Month 6-Month
LV Offset BiV-CRT
All patients with data at a minimum of one visit, N=189
Figure C-3. Improvem ent in Peak V02 at Six Months
Tab le C-4. Improvement in Peak VO2 at six months
Statistic LV Offset BiV-CRT
N
a
Estimate ± SE
N
a
Estimate ± SE
Baseline 89 12.7 ± 0.2 88 12.7 ± 0.2
3 Months 72 14.2 ± 0.3 71 14.5 ± 0.3
6 Months 71 14.3 ± 0.3 76 14.2 ± 0.3
Improvement a t 6 Months 1.6 ± 0.3 1. 5 ± 0.3
Confidence Interval Lower Bound
1.1 1.0
a. N refers to the number of patients with paired data.
Left Ventricular End Systolic Diameter (LVESD)––TheeffectofLV
Offset was also assessed using six-month change in LVESD. A recorded
echocardiographic examination was performed at the randomization visit (prior
to CRT initiation) 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 and clinically mea ningful
improvement (≤ -5 mm) in LVESD (Figure C-4 on page C-9, Table C-5 on
page C-9). The null hypothesis was to be rejected if the upper one-sided 95%
confidence bound were less than zero. The observed upper one-sided bound
for LV Offset is -4.2 mm.
- DRAFT -