User Manual Part 4

CLINICAL STUDY - DECREASE HF
C-13
Table C-10 on page C-13 summarizes the heart failure related adverse event
rates t hro ug h the six-month visit. A Kaplan-Meier analysis is also p re sented in
FigureC-7onpageC-14toshowtimetoevents.
Tab le C-10. Heart failure-related adverse event free rate at six months
Adverse Event
a
Number
of
Events
Number of
Patients
Heart F ailure
Adverse
Event F ree Rate
Lower One-Sid ed 95%
Confidence Bound
Multiple heart failure symptoms
38 29 91.4 88.5
Dyspnea - Heart failure
13 13 96.2 94.0
Heart failure symptoms -
Unspecified
13 12 96.4 94.3
Hypotension - Heart failure
10 9 97.3 95.4
Weight gain - Heart failure
5
4 98.8 97.3
Fatigue - Heart failure
4 4 98.8 97.3
Pulmonary edema - Heart fa ilure
4 4 98.8 97.3
Renal insufficiency - Heart failure
4 3 99.1 97.7
Gastrointestinal - Heart failure
3 3 99.1 97.7
Multi-system failure - Heart failure
2 2 99.4 98.1
Peripheral edema - Heart failure
2 2 99.4 98.1
Chest pain - Heart failure
1 1 99.7 98.6
Dehydration - Heart failure
1 1 99.7 98.6
Dizziness - Heart failure
1 1 99.7 98.6
Elevated BNP - Heart Failure 1 1 99.7 98. 6
Total 102 67 80.2 76.3
a. All patients implanted and active at the randomization visit; N= 338.
The null hypothesis was to be rejected if the lower one-sided 95% confidence
bound for heart failure adverse event free rate through six months post-implant
were greater than 50%. The heart failure related adverse event free rate at six
months was 80.2% with a lower one-sided 95% confidence bound of 76.3%.
- DRAFT -