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

Study Timeline

• Study Start: 2018-11-12
• Primary Completion: 2019-07-17
• Study Completion: 2019-07-22
• Status Verified: 2019-08
• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-27
• Last Update Submitted: 2019-08-29
• Study First Posted: 2019-08-30
• Last Update Posted: 2019-09-03

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