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OpenTrials
Completed

NCT Number: NCT04074434

Study Watch Atrial Fibrillation (AF) Detection Investigation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Diego Cardiac Center

San Diego, California, 92123, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study Watch

Device

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

Primary outcomes

  1. 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)

    Time frame: At least 60 minutes

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

  2. 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.

    Time frame: 14 days

    Number of AF events identified from FDA-cleared ECG Device

Secondary outcomes

  1. 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)

    Time frame: At least 60 minutes

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

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

    Time frame: 14 days

    Qualitative listing of participant-reported feedback

Sponsors and collaborators

Lead sponsor

Verily Life Sciences LLC

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 30, 2019
Registry last updated
Sep 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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