BIOTRONIK Evia DR, Техническое руководство

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Evia Technical Manual 39
E
F F E C T I V E N E S S
The analysis was based on the simple linear regression
(y = m + ax) of the obtained rate-adaptive pacing rate versus the
expected heart rate during a CAEP treadmill test with the device
in patients with a high percentage of ventricular sensing (80% or
more).
S
A F E T Y
This endpoint was based on the analysis of adverse events
(complications and observations) caused by the Protos CLS
devices during this acute study.
6.3.2.2 Methods
A total of 21 patients with previously implanted legally marketed
Protos DR CLS pulse generators were enrolled in a controlled,
prospective study. The investigation was conducted at 5 centers.
The average patient was a 70 year-old male, with sinus
bradycardia.
During a follow-up visit, the pacemakers were downloaded with
the AxVx investigational software. At a second follow-up, the
patient performed a symptom limited CAEP treadmill test.
Following the treadmill testing with the investigational AxVx
algorithm, the pacemaker was downloaded with legally marketed
AxVp software for routine follow-up care.
6.3.2.3 Results
E
F F E C T I V E N E S S
A total of 13 treadmills were included for the analysis of the rate
response slope. The mean rate response slope during the
CAEP treadmill test was 0.66 with standard deviation of 0.23 and
a 95% confidence interval of [0.52, 0.80].
The number and percentages of patients who met the predefined
performance criteria are presented in
Table 7
.