BIOTRONIK Evia DR, Technical Manual

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38 Evia Technical Manual
The increase in heart rate in CLS mode was 18.65 ± 5.77 bpm
compared to 6.99 ± 3.22 bpm in the accelerometer mode. Using
the paired Student’s t-test, the p value was less than 0.001. The
null hypothesis was rejected.
6.3.1.4 Summary and Conclusions
•
A total of 74 patients were enrolled at 16 medical
centers.
•
The study analysis included forty (40) of those 74
patients who met the predefined criteria of at least 80%
sensor driven heart rates during the ER Test©.
•
During the ER Test©, the average sensor driven heart
rate increase for CLS mode was 18.65 ± 5.77 bpm
versus 6.99 ± 3.22 bpm while in accelerometer mode, p
< 0.001.
•
The mean heart rate increase from baseline associated
with the ER Test© for age group 40-60 years was 16.14
± 1.15 bpm and the age group 60+ years was 18.79 ±
5.89 bpm. The rate response provided by CLS is
consistent with those age matched healthy subjects in
the literature.
•
CLS demonstrated an appropriate response to
myocardial contractility changes due to acute mental
stress.
•
All 40 patients (100%) showed a higher peak heart rate
in the CLS pacing mode compared to the accelerometer
pacing mode.
•
In conclusion, BIOTRONIK has shown the effectiveness
of the Protos DR/CLS pacemaker for providing
appropriate rate response as tested during an acute
mental stress test, the ER Test
©
, for patients exhibiting a
high percentage of sensor-driven pacing.
6.3.2 Protos DR CLS with AxVx
6.3.2.1 Primary Objectives
The clinical study included evaluation of the safety and
effectiveness of the device in patients with a high percentage of
ventricular sensing (80% or more) to demonstrate that the AxVx
version of CLS functions appropriately for this type of patients.