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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).

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