BIOTRONIK Cardiac Airbag, Technical Manual, Page: 25 / 92

Cardiac Airbag Technical Manual 19
Table 2: Clinical Study Results
Description Study Group
[95% CI]
Tachyarrhythmia Conversion Rate1
Induced
95.8% (496/518)
[93.6%, 97.3%]
Spontaneous 99.7% (1540/1544)
[99.3%, 99.9%]
Total 98.7% (2036/2062)
[98.2%, 99.2%]
Sudden Cardiac Death Survival
(at one year) 100.0% (39/39)
[91.0%, 100.0%]
Complication Rate
(per total number of patients) 5.2% (8/154)
[2.3%, 10.0%]
Appropriate Sensing and Pacing Rate2
98.0% (703/717)
[96.8%, 98.9%]
1. Conversion data were collected in the clinical study for
both induced and spontaneous tachyarrhythmia
episodes. Therefore, both types of tachyarrhythmia
episodes were included in the analysis.
2. The investigator determined the appropriateness of
bradycardia sensing and pacing. The rate will be
determined by the number of appropriate bradycardia
sensing and pacing evaluations divided by the total
number of evaluations.