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Study Watch Atrial Fibrillation (AF) Detection Investigation

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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

Tracking Information
First Submitted Date August 22, 2019
First Posted Date August 30, 2019
Last Update Posted Date September 2, 2019
Actual Study Start Date November 12, 2018
Actual Primary Completion Date July 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 27, 2019)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04074434 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 27, 2019)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study Watch Atrial Fibrillation (AF) Detection Investigation
Official Title Study Watch Atrial Fibrillation (AF) Detection Investigation
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects with a known history of AF (including persistent or paroxysmal AF)
Condition Atrial Fibrillation
Intervention Device: Study Watch
Study Watch is a miniaturized physiological data monitoring and data collection device for continuous recording of physiological and environmental data
Study Groups/Cohorts All Participants
Intervention: Device: Study Watch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 27, 2019)
160
Original Actual Enrollment Same as current
Actual Study Completion Date July 22, 2019
Actual Primary Completion Date July 17, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04074434
Other Study ID Numbers 100145
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Verily Life Sciences LLC
Study Sponsor Verily Life Sciences LLC
Collaborators Not Provided
Investigators Not Provided
PRS Account Verily Life Sciences LLC
Verification Date August 2019