User Manual Part 4

D-24
CLINICAL STU DY - CONTAK CD
Tab le D-18. Reasons for un successful EASYTRAK lead implant (continued)
Reason
#ofpts
a
%
Extracardiac stimulation 1 1.4
Inability to place an atrial pace/sense lead
11.4
Tota l 69 100
a. Patients with unsuccessful attempt to im plant EASYTRAK lead; N = 69.
Tab le D-19. EASYTRAK lead placement success rate
Measurement All Pro cedu res
a
Number of patients implanted or attempted
517
Number of placements of the EASYTRAK Lead
b
448
Rate
87%
95% CI (84%, 90%)
a. All patients im planted or attempted with EASYTRAK lead; N = 517.
b. Defined as an EASYTRAK implant procedure that is concluded with the implant of the investigational cardiac resynchronization
system.
Although some situations such as patient anatomy and poor thresholds cannot
be avoided, increased investigator experience with the EASYTRAK lead and
accessories was associated with improved success, decreased total procedure
time (measured skin-to-skin), and decreased fluoroscopy exposure time
(FigureD-10onpageD-24).
95
Implant Success Rate (%)
90
85
80
0
8-15 >15 4-7 1-3
250
Mean Procedure Time (min)
200
150
100
0
8-15 >15 4-7 1-3
60
Mean Fluoroscopy Exposure Time (min)
50
40
30
0
8-15 >15 4-7 1-3
Mean ± SEMean ± SE
Implants (by order of enrollment)
Figure D-10. EASYTRAK success rate, procedu re time, and fluoroscopy exposure time
- DRAFT -