User Manual Part 4

CLINICAL STUDY - SUMMARY OF CRT OPTIMIZ
ATION ALGORITHM VALIDATION STUDY
F-9
Tab le F-6. Differences between maximal ach ievab le %Ao VTI an d that achie ved usi ng the EEHF+ and a fixed
AV delay of 100 ms, 120 ms, 140 ms, and 160 ms d urin g atrial sensing. (continued)
n, mean ± std, 95% CI n, mean ± std, 95% CI n, mean ± std, 95% C I
Paired t-test
EEHF+ 160 ms
Paired difference
P-value
36, - 8.5 ± 8.3, (-11.2, -5.8) 36, -7.3 ± 6.4, (-9.4, -5.2) 36, 1.2 ± 9.8, (-2.0, 4.4)
0.4769
Tab le F-7. Differences between maximal ach ievab le %Ao VTI an d that achie ved usi ng the EEHF+ and a fixed
AV delay of 100 ms, 120 ms, 140 ms, and 160 ms du r ing atrial pacing
n, mean ± std, 95% CI n, mean ± std, 95% CI n, mean ± std, 95% C I
Paired t-test
EEHF+ 100 ms
Paired difference
P-value
35, -6.6 ± 5.2, (-8.3, -4.8) 35, -11.9 ± 6.4, (-14.0,
-9.8)
35, -5.4 ± 9. 3, (-8.4, -2.3)
0.0017
EEHF+ 120 ms
Paired difference
P-value
34, -6.4 ± 5.3, (-8.2, -4.7) 34, -9.3 ± 7.1, (-11.7, -6.9) 34, -2.8 ± 9.9, ( -6.2, 0.5)
0.1046
EEHF+ 140 ms
Paired difference
P-value
35, -6.6 ± 5.2, (-8.3, -4.8) 35, -7.9 ± 5.3, (-9.7, -6.2) 35, -1.4 ± 7.7, (-3.9, 1.2)
0.2977
EEHF+ 160 ms
Paired difference
P-value
35, -6.6 ± 5.2, (-8.3, -4.8) 35, -7.1 ± 5.4, (-8.9, -5.3) 35, -0.5 ± 7.7, (-3.1, 2.0)
0.6896
Comparison of EEHF+ recommended AV delay to echo-based Ritter
method in achieving AoVTI
max
• As shown in the tables below, there was a large variance in the difference
in %AoVTI obtain ed with E E HF+ and that obtained with Ritter method in
atrial sensing mode and atrial pacing mode; the tables also provide further
details about the number of subjects, mean, standard deviation, p-value,
and co nfidence interval (Table F-8 on page F-10, Table F-9 on page F-10).
- DRAFT -