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Study Watch Atrial Fibrillation (AF) Detection Investigation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074434
Recruitment Status : Completed
First Posted : August 30, 2019
Last Update Posted : September 2, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Atrial Fibrillation Device: Study Watch

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Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study Watch Atrial Fibrillation (AF) Detection Investigation
Actual Study Start Date : November 12, 2018
Actual Primary Completion Date : July 17, 2019
Actual Study Completion Date : July 22, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with a known history of AF (including persistent or paroxysmal AF)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074434


Locations
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United States, California
San Diego Cardiac Center
San Diego, California, United States, 92123
Sponsors and Collaborators
Verily Life Sciences LLC

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Responsible Party: Verily Life Sciences LLC
ClinicalTrials.gov Identifier: NCT04074434     History of Changes
Other Study ID Numbers: 100145
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes