Study Watch Atrial Fibrillation (AF) Detection Investigation
Completed
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT04074434
- Lead Sponsor
- Verily Life Sciences LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
San Diego Cardiac Center
🇺🇸San Diego, California, United States
San Diego Cardiac Center🇺🇸San Diego, California, United States