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Stratos LV/LV-T Technical Manual 29
Primary Endpoint—Complication-free Rate (Safety)
The safety of the Stratos LV was evaluated based on
complications (adverse events that require additional invasive
intervention to resolve) related to the implanted CRT system
which includes the Stratos LV, the right ventricular, the left
ventricular lead, lead ventricular lead adapters (if used) and the
implant procedure. The target complication-free rate at six
months is 85%.
13 complications in these categories were seen in 11 patients
with cumulative enrollment duration of 783.5 months
(64.4 patient-years). 14.7% of the patients had a reported
complication in these categories. The rate of complications per
patient-year is 0.20. Details of the Stratos LV complications in
the AVAIL CLS/CRT study are listed in Table 4
.