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3 years ago

Slides - Clinical Trial Results

Slides - Clinical Trial Results

Follow-up and

Follow-up and EndpointsFollow-up schedule:• ECG at outpatient clinic 1, 3, 6, 12 mo, or anytime during complaints• 7-day Holter performed at 6, 12 moPrimary Efficacy Endpoint after 12-mo:• Freedom of LA arrhythmia lasting >30 sec in the absence of Class I&III AADPrimary Safety Endpoint after 12-mo:• Significant Adverse Event rate both procedural and chronicStatistical analysis:• 124 pts were randomized assuming an efficacy of CA 60% and SA 85%,power of 80% (1-sided Fishers Exact test), significance level 0.025• Outcome measures: 2-sided Pearsons’ Chi-square test/Yates continuitycorrection, Odds ratios with 95% CI, and Fishers Exact test

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