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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
NameTimeMethod
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
NameTimeMethod
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

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