User Manual Part 4

F-6
CLINICAL STUDY - SUMMARY OF CRT OPTIMIZ
ATION ALGORITHM VALIDATION STUDY
Table F-2. Differences between maximal achievable %LV dP/dt max and that achieved using EEHF+ and a
fixed AV dela y o f 100 m s , 120 m s, 140 ms and 160 ms, during 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
33, -1.1 ± 1.3, (-1.6, -0.7) 33, -3.6 ± 3.8, (-4.9, -2.3) 3 3, -2.5 ± 4.0, (-3.8, -1.1)
0.0013
Table F-3. Differences between maximal achievable %LV dP/dt max and that achieved using EEHF+ and a
fixed AV delay of 100 ms, 120 ms, 140 ms a nd 160 ms, d urin g 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
36, -2.0 ± 2.6, (-2.8, -1.1) 36, -8.7 ± 5.1, (-10.3, -7.0) 36, -6.7 ± 4.8, (-8.3, -5.2)
< 0.0001
EEHF+ 120 ms
Paired difference
P-value
36, -2.0 ± 2.6, (-2.8, -1.1) 36, -6.5 ± 4.7, (-8.0, -4.9) 3 6, -4.5 ± 4.2, (-5.9, -3.2)
< 0.0001
EEHF+ 140 ms
Paired difference
P-value
36, -2.0 ± 2.6, (-2.8, -1.1) 36, -4.7 ± 4.2, (-6.1, -3.3) 3 6, -2.7 ± 3.5, (-3.9, -1.6)
< 0.0001
EEHF+ 160 ms
Paired difference
P-value
36, -2.0 ± 2.6, (-2.8, -1.1) 36, -3.4 ± 3.6, (-4.5, -2.2) 3 6, -1.4 ± 2.8, (-2.3, -0.5)
0.0049
Comparison of EEHF+ recommended AV delay to the echo-based Ritter
and AoVTI methods in achieving LV dP/dt
max
• Differences between the %LV dP/dt
max
achieved with EEHF+ and the %LV
dP/dt
max
achieved with the Ritter and AoVTI echo methods were plotted for
the two echo methods (Figure F-3 on page F-7). A negative value indicated
that the LV dP/d t
max
achieved with EEHF+ was higher. See the tables
below for further details about the number of subjects, m ean, standard
deviation, p-value, and confidence interval for each comparison (Table F-4
on page F-7, Table F-5 on page F-7).
- DRAFT -