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Stratos LV/LV-T Technical Manual 43
Safety and Effectiveness Results
• The cumulative implant duration was 760 months with a
mean duration of 9.2 months. Sixty-five (77%) of the
patients had implant durations greater than 6 months.
• The implant success rate for the Stratos LV CRT-P was
100% (89 out of 89). The implant success of the
Stratos LV CRT-P in combination with the
Corox OTW/Steroid LV lead was 94.4% (84 out of 89).
• The mean LV pacing threshold at implant was 0.9 and at
6-months was 0.9 volts.
• The mean R-wave at implant was 15.7 mV.
• The mean LV lead impedance at implant was 729 ohms
and at 6-months was 603 ohms.
• There were 29 adverse events (18 observations in
17 patients and 11 complications in 10 patients). There
were no unanticipated adverse device effects reported.
• There were 10 patient deaths reported in the OVID
study. The clinical investigators have determined that
no deaths were related to the Stratos LV CRT-P system.
• The overall follow-up compliance rate for the OVID study
is 93%.
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 device, the atrial lead, the right
ventricular lead, the left ventricular lead and the implant
procedure. The target complication-free rate at six months was
85%.
Ten (10) complications in these categories were seen in
10 patients with cumulative implant duration of 760 months
(63.3 patient-years). 11.2% of the patients had a reported
complication in these categories. The rate of complications per
patient-year was 0.16. Details of the Stratos LV complications in
the OVID study are listed in Table 10
.