User Manual Part 4

CLINICAL STUDY - C ONTAK CD
D-21
shown in Figure D-7 on page D-21 and Table D-15 on page D-21 are well
within this limit.
6
4
2
0
LV Pacing Threshold (V at 0.5 ms)
02418126
Acceptance Boundary
90% Tolerance Interval
Implant Duration (months)
Figure D-7. EASYTRAK lead thresho ld measurements
Tab le D-15. EASYTRAK lead threshold measurements
Statistic
a
Implant 3 Months 6 Months 12 Months 18 M onths 24 Months
N 435 347 330 233 103 25
Mean ± SD
1.8 ± 1.2 1.7 ± 1.3 1.9 ± 1.5 1.8 ± 1.2 1.8 ± 1.1 2.0 ± 1.2
Range 0.2 - 7.5 0.2 - 7.5 0.2 - 7.5 0.4 - 7.5 0.6 - 7.5 0.6 - 5.0
Upper Tolerance Limit 3.8 3.8 4.3 3.8 3. 7 3.9
a. EASYTRAK lead models: 4511, 4512, and 4513
Mean chronic biventricular R-wave amplitudes are measured as a combination
of the R-waves from both the right ventricle (commercially available ENDOTAK
lead) and left ventricle (EASYTRAK lead). It was hypothesized that the mean
biventricularR-waveamplitudebegreaterthan5mVtoensurepropersensing.
InFigureD-8onpageD-22andTableD-16onpageD-22,theperformanceof
the EA SYT RAK lead s ystem was significantly above this value (p < 0.01).
- DRAFT -