Atrial Fibrillation
Conditions
Brief summary
This is a prospective, non-randomized study to refine the Study Watch's algorithm for AF detection within both persistent and paroxysmal AF subjects. The study will also collect data from an FDA-cleared wearable ECG sensor.
Interventions
DEVICEStudy Watch
Study Watch is a miniaturized physiological data monitoring and data collection device for continuous recording of physiological and environmental data
Sponsors
Verily Life Sciences LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years old * Able to read and speak English * Able and willing to sign written Informed Consent * Interest in participating in the study * Subjects with a known history of AF (including persistent or paroxysmal AF) * Without significant limitation in ability to participate in the study, in the opinion of the investigator.
Exclusion criteria
* Currently in a paced rhythm * Known severe allergy to nickel or metal jewelry * Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF) | At least 60 minutes | Sensitivity estimate for PPG irregular rhythm detection vs. a multi-lead Holter ECG rhythm |
| PPG- and ECG-based continuous AF-detection algorithms on Study Watch in a free-living (home) setting by comparing the Study Watch data with an FDA-cleared wearable ECG sensor data. | 14 days | Number of AF events identified from FDA-cleared ECG Device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF) | At least 60 minutes | Predictive value estimate for PPG irregular rhythm detection vs. a multi-lead Holter ECG rhythm |
| Spontaneously-reported participant usability feedback for Study Watch and its ECG feature in a free-living (home) setting with the target AF population. | 14 days | Qualitative listing of participant-reported feedback |
Countries
United States
Outcome results
None listed