English to Russian Other Medical: Cardiology

A total of 146 subjects had paired sensed amplitude measurements and were included
in the endpoint analysis. The success rate was 99.32% with a 95% one-sided LCL of
96.79%, which is greater than the performance goal of 85%. The observed 99.32%
success rate with a lower confidence bound of 96.79% is significantly higher than the
performance goal of 85%. This data supports the effectiveness of the ImageReady
System with respect to stable RV sensed amplitude pre- and post-MR scan (a surrogate
measurement for clinical effects of lead heating) when subjects are scanned according
to the labeled MRI Conditions of Use.