BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 48 / 176

40 Lumax Technical Manual
1.6.2.10 Secondary Endpoint Results
1. The purpose of Secondary Endpoint 1 is to evaluate the
overall ability of the Tupos LV/ATx to appropriately convert
spontaneous AT (atrial tachycardia) and AF (atrial fibrillation).
The results from the OPTION study were compared to the
results from BIOTRONIK’s TACT study (P000009/S4, dated
09-09-2002) that demonstrated the effectiveness of these
atrial therapy features in the Tachos DR - Atrial Tx ICD.
Table 11 summarizes success rates for each individual atrial
tachyarrhythmia therapy type and overall success rate from
the OPTION study compared to the TACT study. The
number of episodes and patients receiving any therapy is less
than the total episodes of each therapy type, as episodes
may have included more than one type of therapy.
Table 11 Overall Atrial Conversion Rate
OPTION Study
Patients
Patients Success Episodes
Conversion
rate
ATP 3 3 5 60.0%
HF Burst 17 45 111 40.5%
Shock 12 30 34 88.2%
All
Therapies
25 78 129 60.5%
TACT Study
ATP 29 62 142 43.6 %
HF Burst 49 156 408 38.2 %
Shock 42 84 108 77.8 %
All
Therapies
66 302 542 55.7 %
The overall conversion rate and the conversion rates for each
therapy are comparable to the conversion rates observed in
the TACT study, demonstrating that the Tupos LV/ATx device
has similar atrial conversion capabilities as the legally
marketed Tachos DR – Atrial Tx ICD.