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Stratos LV/LV-T Technical Manual  43 

•  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%. 

 

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 

.