Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Subjects whose ECG is interpreted as normal sinus rhythm during the screening assessment |
| |
| Cohort 2 | Subjects whose ECG is interpreted as atrial fibrillation during the screening assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrocardiogram recording | Device | ECG recording with investigational device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 Day |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
-Subjects with an implantable pacemaker device or implantable cardioverter- defibrillator device.
Not provided
Not provided
Not provided
The study population will include adults seen in primary care and cardiology clinics associated with a single health system or subjects recruited through study advertisement. The prospective cohort will comprise two distinct populations - individuals with a known history of persistent atrial fibrillation and individuals without a history of cardiac arrhythmia of any kind.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gerald Early, M.D. | IQVIA Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOPE Research Institute | Phoenix | Arizona | 85018 | United States | ||
| Valley Clinical Trials |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
| Covina |
| California |
| 91723 |
| United States |
| Valley Clinical Trials | Northridge | California | 91325 | United States |
| Flourish Research | Winter Park | Florida | 32789 | United States |
| IQVIA | Lenexa | Kansas | 66219 | United States |
| Fairview Frontiers | Saint Paul | Minnesota | 55102 | United States |
| Eximia Research-NC, LLC | Raleigh | North Carolina | 27607 | United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |