BIOTRONIK Evia DR, Техническое руководство

Страница: 36 / 183

28 Evia Technical Manual
Table 4: Dromos DR Metabolic Exercise Testing at 6 Weeks
Endpoints DDDR
Mode
DDD
Mode
Difference
(CI)
Maximum VO
2
(mL/kg/minute)
20.4 ±
8.0
17.8 ±
6.2
2.67* ± 2.77
[1.5, 3.8]
VO
2
@ AT
(mL/kg/minute)
14.6 ±
3.6
13.1 ±
4.0
1.5* ± 2.71
[0.33, 2.6]
Total exercise time
(minutes) 9.2 ± 3.0 8.2 ± 3.3 0.92* ± 1.08
[0.45,1.4]
Exercise time to AT
(minutes) 6.3 ± 2.4 5.7 ± 2.8 0.69* ± 1.43
[0.04, 1.3]
Heart rate @AT (bpm) 113 ± 16 84 ±
16.5 29* ± 18
[21,37]
All chronotropically incompetent patients tested,
n =21, Mean ±SD and [95% confidence interval]
95% confidence interval = mean difference ± 1.96 SEM
*Difference statistically significant, p<0.05 by paired t-test
There were no pulse generator-related deaths or unusual rates
of observations or complications (see
Section 5
, Adverse
Events).
Conclusions:
No unusual safety concerns were raised by the
results of the clinical study. The accelerometer-based motion
sensor provided the patients with appropriate rate-adaptation
when programmed according to the sensor parameter
optimization procedure. Additionally, the DDDR mode provided
statistically significant improvement in metabolic measures
during paired exercise testing of CI patients at 6 weeks.
6.2 Ventricular Capture Control
All references to Active Capture Control feature are now
synonymous with Ventricular Capture Control (VCC) in the Evia
devices. The clinical study involved 151 patients, of which 72
were male (47.7%) and 79 were female (52.3%) with a mean
age of 72 years (range: 30-93 years). The majority of patients
presented with an abnormal sino-atrial node (85%) and an
abnormal conduction system (57%) at implant.