Study Watch Atrial Fibrillation (AF) Detection Investigation

NCT ID: NCT04074434

Last Updated: 2019-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-12

Study Completion Date

2019-07-22

Brief Summary

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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

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All Participants

Study Watch

Intervention Type DEVICE

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

Interventions

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Study Watch

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Verily Life Sciences LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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San Diego Cardiac Center

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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100145

Identifier Type: -

Identifier Source: org_study_id

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