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.
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).
Study Type
OBSERVATIONAL
Enrollment
540
ECG recording with investigational device
HOPE Research Institute
Phoenix, Arizona, United States
Valley Clinical Trials
Covina, California, United States
Valley Clinical Trials
Northridge, California, United States
Flourish Research
Winter Park, Florida, United States
Specificity of the WHOOP ECG Feature for detection of sinus rhythm
Specificity is defined as the True Negatives/(True Negatives + False Positives). A true normal sinus rhythm reading will have a 12-lead ECG reading consistent with normal sinus rhythm. A true negative is defined as individuals who have normal sinus rhythm reported on their ECGs from both the WHOOP ECG Feature and the 12-lead ECG Holter Device. A false positive is defined as individuals who receive an ECG with atrial fibrillation by the WHOOP ECG Feature but their 12-lead ECG has an atrial fibrillation determined by adjudication.
Time frame: 1 Day
Sensitivity of the WHOOP ECG Feature for detection of atrial fibrillation
Sensitivity is defined as the True Positives/(True Positives + False Negatives). A true atrial fibrillation reading will have an 12-lead ECG reading consistent with atrial fibrillation. A true positive is defined as individuals who have atrial fibrillation reported on their WHOOP ECGs and on the 12-lead ECG from the Holter Device. A false negative is defined as individuals who receive an ECG with atrial fibrillation with the 12-lead ECG as determined by adjudication but their WHOOP ECG Feature determination is Normal Sinus Rhythm.
Time frame: 1 Day
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IQVIA
Lenexa, Kansas, United States
Fairview Frontiers
Saint Paul, Minnesota, United States
Eximia Research-NC, LLC
Raleigh, North Carolina, United States