User Manual Part 4

CLINICAL STUDY - SUMMARY OF CRT OPTIMIZ
ATION ALGORITHM VALIDATION STUDY
F-3
Tab le F-1. Subject Demographics
Characteristic
Measurement Result
Age at Implant
Number of subjects
50
Mean ± SD
68.1 ± 10.5
Range [47.0, 85.0]
Gender [N (%)]
Female
12 (24.0)
Male
38 (76.0)
NYHA Class [N (%)]
II
1(2.0)
III
49 (98.0)
LVEF
Number of subjects
50
Mean ± SD
26.6 ± 6.6
Range [5.0, 35.0]
Conduction Disorder
LBBB
38 (86.4)
RBBB
12 (27.3)
LV DP/dt
max
Results
Correlation between the LV dP/dt
max
at the EEHF+ recommended AV
delay and maximum achievable LV dP/dt
max
• For the regression analysis, the 95% confidence intervals of the regression
slope were [0.98, 1.07] and [0.94, 1.10] for atrial sensing and pacing. The
corresponding intercept values were [-2.07, -0.86] and [-3.73, -0.76] for
atrial sensing and pacing (Figure F-1 on p a ge F -4). The ability of EEHF+ to
suggest an AV delay that maximizes %LV dP/dt
max
for both atrial sensing
and atrial pacing is demonstrated in the regression plots. For patients
with a near-zero maximum improvement in %LV dP/ dt
max
from baseline,
the %LV dP/ dt
max
at the AV delay estimated by EEHF+ was close to the
maximum achievable %LV dP/dt
max
as indicated by the small intercept
(-1.47 for atrial sensing and -2.25 for atrial pacing).
- DRAFT -