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Stratos LV/LV-T Technical Manual 41
Clinical Endpoints
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%.
Accountability of PMA Cohorts
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.
Demographics and Baseline Parameters
Table 9
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.