BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 40 / 176

32 Lumax Technical Manual
•
Acute myocardial infarction, unstable angina or cardiac
revascularization within the last 30 days prior to
enrollment
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Conditions that prohibit placement of any of the lead
systems
1.6.2.3 Summary of Clinical Results
A total of 200 patients were enrolled in the OPTION CRT/ATx
clinical study at 25 sites:
There were 133 study patients and 67 active control patients in
this prospective, multi-center, randomized clinical study. For the
study group, there were 129 successful implants (91.4%) of the
Tupos LV/ATx CRT-D system. For the active control group, there
were 64 successful implants (92.2%) of the legally marketed
CRT-D systems.
Patient Accountability
After randomization and enrollment, 7 patients (4 in the study
group and 3 in the control group) did not receive an implant. The
reasons for patients not receiving an implant are outlined in
Figure 2 .