In this study, we will evaluate the diagnostic yield of the new AliveCor device versus a 14 day event monitor with the use of both devices simultaneously. We will also examine by means of a questionnaire the compliance, ease of use and patient satisfaction for each device. Hypothesis: 1. The AliveCor monitor will be non-inferior to the 14 day event monitor with respect to diagnosis of the arrhythmia responsible for a patient's symptoms. 2. The AliveCor monitor will have better compliance and acceptability compared to the 14 day event monitor, and thus there will be a greater number of days with recordings from the AliveCor monitor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
38
Alivecor monitor and 14 day event monitor
Dent Towers
Buffalo, New York, United States
Validation of an iPhone-based Event Recorder for Arrhythmia Detection
For the primary endpoint, equivalence testing using the two one-sided test (TOST) procedure was used to compare the proportion of unpaired days in which a diagnostic recording was made with each device during the monitoring period. A difference of less than 10% between the devices on the rate of detection of arrhythmias was taken to indicate equivalence.
Time frame: one year
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