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. 2022 Mar 21;9:839202. doi: 10.3389/fcvm.2022.839202

TABLE 1.

Primary outcome and key secondary outcomes of Smart in OAC – AFNET 9.

1. Primary Outcome
The primary endpoint is the proportion of participants with newly detected atrial arrhythmias within 4 weeks of device use of all participants included in the study. It will be reported with a two-sided 95% Clopper-Pearson confidence interval.
2. Key Secondary Outcomes
Proportion of participants with atrial arrhythmias detected at any time, including those with atrial arrhythmias detected within the full time of recording will be reported with a two-sided 95% Clopper-Pearson confidence interval
Time from completed enrolment to the first positive screening, taking death as competing risk into account will be analysed using Aalen–Johansen curves.
Regional differences of atrial arrhythmia prevalence (diagnostic yield), differences by route of invitation and enrolment will be compared using a logistic regression model
Differences by route of invitation and enrolment will be compared using a logistic regression model
Compliance: The compliance of participants with protocol with regards to the measurement procedure of the app and wearable will be presented descriptively. This will include reasons to discontinue the monitoring prematurely, and reasons for withdrawal of consent. The duration of screening per participant will be plotted. Proportion of participants with atrial arrhythmias contacting the study centre (personal visit or remote),as recommended. Number of participants wearing the 14 day Tele ECG patch after detection of atrial arrhythmias; Compliance of participants using the app/wearable: percentage of active users after two weeks, histogram of analysable data recorded.
Detection of AF: Number of participants with clinically confirmed arrhythmias (sub-analysis: AF) during Holter ECG, documented clinically or by event-recorder. We will add clinical evidence as available. The agreement of ECG-based detection of AF will be accessed by cross-tabulating both methods and quantified using the proportion of concordant diagnoses in the ECG subpopulation.