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Stratos LV/LV-T Technical Manual 61
1.7.5 Conclusions Drawn from Studies
The clinical study results support the safety and effectiveness of
the Stratos LV CRT-P device.
• The OPTION CRT/ATx clinical study completed and
reviewed under P050023 provided a reasonable
assurance that bi-ventricular pacing is effective in NYHA
class III/IV heart failure patients with a prolonged QRS
and a left ventricular ejection fraction <35%. The
addition of ICD back-up therapy does not affect the
biventricular pacing performance of the device.
• The AVAIL CLS/CRT and Corox (OVID) clinical studies
demonstrated the safety of the Stratos LV CRT-P in
NYHA class III/IV heart failure patients with a prolonged
QRS and a left ventricular ejection fraction
<35%.(OVID).