User Manual Part 4

CLINICAL STUDY - C ONTAK CD
D-31
Tab le D-26. Pre-implant charac teristics of study patients
Characteristics All Patients Receiving CRT
Age (years)
61 ± 12
Male G ender (%)
69
NYHA Class III (%)
94
Ischemic Etiology (%)
49
Resting heart rate (bpm)
73 ± 12
QRS w idth (ms)
159 ± 27
LBBB/NSIVCD (%)
91
Heart failure medications (%)
ACE inhibitor or ARB
91
Beta blockers
77
Digoxin 76
Diuretics 98
Inclusion Criteria
Inclusion criteria included:
• Moderate or severe heart failure, defined as symptomatic heart failure
for at least six months with NYHA Class III or IV sym ptoms at the time
of enrollment, AND at least one of the following events in the previous
12 months:
– Hospitalization for heart failure management
– Outpatient visit in which intravenous (IV) inotropes or vasoactive
infusion were administered continuously for at least 4 hours
– Emergency room visit of at least twelve hours duration in which IV
heart fa ilure medications were adm in istered (including diuretics)
•QRS≥ 120 ms and PR interval > 150 ms from any two leads of a 12-lead
ECG
• Left ventricula r ejection fraction ≤ 35%
• Left ventricular end diastolic dimension ≥ 60 mm (required only if LVEF
measured by echo)
- DRAFT -