User Manual Part 4

D-10
CLINICAL STU DY - CONTAK CD
Control (No CRT)
n = 245
Assessable for
effectiveness
n = 224
Assessable for
effectiveness
n = 232
CRT
n = 245
Randomized
n = 490
16
2
3
0
Death
Uncorrected lead dislodgement
Heart transplant
Withdrew
11
0
1
1
Six months
n = 125
Three months
n = 99
Six months
n = 126
Three months
n = 106
10
1
Death
Withdrew
Implanted
n = 501
14
66
Withdrew prior to surgery (“Intent”)
Unable to implant lead (“Attempt”)
Enrolled
n = 581
Figure D-1. Enro llmen t and follow-up of randomized patients
Baseline Characteristics––Includes all patients implanted; N = 501(Table D-3
on page D-11, Table D-4 on page D -12).
- DRAFT -