User Manual Part 4

C-12
CLINICAL STUD Y - DECREASE HF
Table C-8. Six-month change in NYHA by treatment group (continued)
6-Month Change in NYHA
a
LV Offset (N=95) BiV-CRT (N=92) Total (N=187)
No Change 35 (36.8) 36 (39.1) 71 (38.0)
Worsened 1 Class 6 (6.3) 2 (2.2) 8 (4.3)
a. All patients with paired data; N=187.
Device Effectiveness
Primary Endpoint
Ventricular Tachycardia/Fibrillation Detection Time––The objective of this
endpoint was to de monstrate that CRT does not affect the ability to detec t
VT/VF. The results for VT/VF detection time are shown in Table C-9 on page
C-12.
Table C-9. VT/VF detection time
Number of Patients
a
Mean
SD Upper Bound of One-Sided
95% Confidence Interval
338 2.46 0.58 2.50
a. All patients implanted with non-missing data; N=338.
The null hypothesis was to be rejected if the upper one-sided 95% confidence
bound for mean VF detection time were less than 6 seconds. The observed
upper one-sided 95% confidence bound for VF detection time was 2.50
seconds. These data demonstrate device effectiveness in the detection of
VT/VF.
Therapy Safety
Primary Endpoint
Heart Failure-Related Adverse Event Free R ate––Therapy safety was
assessed by the heart failure related adverse event free rate observed
through six months of therapy delivery (randomization visit through six months
post-randomization). The heart failure related adverse event free rate is
defined as the number of patients who do not experience a heart failure related
adverse event divided by the total number of patients implanted and active
at the randomization visit. All patients who were successfully implanted and
remained active at the randomization visit were included in the analysis.
- DRAFT -