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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Study Watch

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • San Diego Cardiac Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with a known history of AF (including persistent or paroxysmal AF)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Participants	Device: Study Watch; Study Watch is a miniaturized physiological data monitoring and data collection device for continuous recording of physiological and environmental data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	14 days

Collaborators and Investigators

• Sponsor: Verily Life Sciences LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Actual): July 17, 2019
• Study Completion (Actual): July 22, 2019

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 100145

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No