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Stratos LV/LV-T Technical Manual  41 

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%. 

During the OVID study, 84 patients were implanted with the 
Stratos LV CRT-P and Corox OTW/Steroid LV lead system.  
Additionally, 5 other patients were implanted with a Stratos LV 
CRT-P device following an unsuccessful Corox OTW/Steroid LV 
lead implant attempt.  Of these 5 patients, three were not 
implanted with any LV pacing lead, one was implanted with a 
non-study LV pacing lead and one was implanted with a 
BIOTRONIK Elox P 60 BP placed in the RV outflow tract for 
bi-focal ventricular pacing.  These 5 patients were excluded from 
the OVID study at 1 month post-implant, because the primary 
endpoint of the OVID study was the evaluation of the safety and 
effectiveness of the Corox OTW/Steroid lead. 

 provides a summary of the patient demographics and 

medical history for the 89 enrolled patients implanted with a 
Stratos LV.  The typical patient implanted with a Stratos LV 
CRT-P was a 68 year old male with NYHA Class III heart failure, 
Left Bundle Branch Block (LBBB), a mean QRS duration of 
160 ms, and non-ischemic cardiomyopathy.