Study Watch Atrial Fibrillation (AF) Detection Investigation

Verily Life Sciences LLC160 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Atrial Fibrillation

Interventions

Study WatchDEVICE

Study Watch is a miniaturized physiological data monitoring and data collection device for continuous recording of physiological and environmental data

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

San Diego Cardiac Center

San Diego, California, United States

Outcomes

Primary Outcomes

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)

Sensitivity estimate for PPG irregular rhythm detection vs. a multi-lead Holter ECG rhythm

Time frame: At least 60 minutes

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.

Number of AF events identified from FDA-cleared ECG Device

Time frame: 14 days

Secondary Outcomes

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)

Predictive value estimate for PPG irregular rhythm detection vs. a multi-lead Holter ECG rhythm

Time frame: At least 60 minutes

Spontaneously-reported participant usability feedback for Study Watch and its ECG feature in a free-living (home) setting with the target AF population.

Qualitative listing of participant-reported feedback

Time frame: 14 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.