User Manual Part 4

C-10
CLINICAL STUD Y - DECREASE HF
upper one-sided 95% confidence bound were less than zero. The observed
upper one-sided confidence bound for LV Offset was -19.4 points.
20
QOL Score
Baseline 3-Month 6-Month
LV Offset BiV-CRT
All patients with data at a minimum of one visit, N=205
30
40
50
60
Figure C-5. Improvement in Quality of Life at Six months
Table C-6. Improvement in QOL at six months.
Statistic LV Offset BiV-CRT
N
a
Estimate ± SE
N
a
Estimate ± S E
Baseline 100 54.6 ± 1.4 98 54.6 ± 1.4
3 Months 94 33.5 ± 2.4 95 34.0 ± 2.3
6 Months 88 31.3 ± 2.4 91 32.5 ± 2.4
Improvement at 6 Months -23.4 ± 2.4 -22.1 ± 2.4
Confidence Interval Upper Bound
-19.4 -18.1
a. N refers to the number of patients with paired data.
NYHA Class––The effect of CRT on the patient’s heart failure related
symptoms (as measured b y NYHA Class) was assess ed prior to imp lant and
subsequently at the three-month and six-month visits. The analysis of NYHA
Class included all patients with data at enrollment and six months.
As shown in Figure C-6 on page C-11 and Table C-7 on page C-11, both arms
showed a statistically significant percentage of patients who improved at least
one NYHA Class, an endpoint considered clinically meaningful in previous
randomized controlled trials of CRT. The null hypothesis was to be rejected
- DRAFT -