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The purpose of the study is to evaluate the performance of ECG classification algorithms and their ability to classify heart rhythms into multiple categories of rhythms and heart rates.
Full description
Atrial fibrillation (Afib) is the most common cardiac arrhythmia in the United States, affecting up to one in four individuals across the lifespan, and is associated with substantial morbidity and mortality. Fifteen percent of strokes in the United States are attributable to Afib, and nearly 20% of these occur in individuals with no prior Afib history. Because Afib is often paroxysmal, one-time screening is unlikely to capture those at risk. Thus, there has been an increasing interest in leveraging monitoring for Afib via wearable devices, which provide a novel method to monitor Afib and determine the burden of Afib in the general population.
The primary objective of this study is to assess the sensitivity and specificity of the investigation device (WHOOP ECG Feature) for the detection of Afib as compared to a gold-standard reference (12-Lead ECG Holter Device).
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-Subjects with an implantable pacemaker device or implantable cardioverter- defibrillator device.
540 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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