User Manual Part 4

CLINICAL STUDY - DECREASE HF
C-11
if the lower one-sided 95% confidence bound of the percentage of patients
improving one or more NYHA Class were greater than zero. The observed
lower one-sided confidence bound for LV Offset w as 47.9%.
100
Percent of Patients Improved
LV Offset BiV-CRT
All patients with data at a minimum of one visit, N=187
60
40
20
0
80
Figure C-6. Improveme nt in NYHA Class at Six Months
Tab le C-7. Improvement in NYHA Class at six month s
Statistic LV Offset BiV-CRT
Total Patients 95 92
Number (Percen t) of Patients Improved 54 (56.8% ) 54 (58.7%)
Lower Bound of One-Sided Exact 95% Confidence Interval 47.9% 49.6%
Table C-8 on page C-11 provides additional detail, showing the percent of
patients who improved two or three classes, as well as the percent of those
who had no change or worsened.
Table C-8. Six-month change in NYHA by treatment group
6-Month Change in NYHA
a
LV Offset (N=95) BiV-CRT (N=92) Total (N=187)
Improved 3 Classes 1 (1.1) 0 (0.0) 1 (0.5)
Improved 2 Classes 16 (16.8) 8 (8.7) 24 (12.8)
Improved 1 Class 37 (38.9) 46 (50.0) 83 (44.4)
- DRAFT -