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Study Watch AF Detection At Home

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: NCT04546763
Recruitment Status : Completed
First Posted : September 14, 2020
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Verily Life Sciences LLC

Brief Summary:
This is a multi-center, prospective, non-randomized study to evaluate the performance of the study watch PPG algorithm in detecting irregular rhythms suggestive of atrial fibrillation (AF) in subjects at risk of having an event of AF in the free living (home) environment.

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

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Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study Watch AF Detection At Home
Actual Study Start Date : September 3, 2020
Actual Primary Completion Date : May 14, 2021
Actual Study Completion Date : May 14, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Paroxysmal Atrial Fibrillation Patients
This will be a single arm study of patients with paroxysmal atrial fibrillation. Subjects will be wearing the Study Watch and Zio XT Patch concurrently for up to 14 days.
Device: Study Watch
The Study Watch is a miniaturized wearable device made with biocompatible contact materials containing various sensors capable of measuring physiological and environmental metrics.

Device: Zio XT
The Zio XT Patch, the reference device, is a FDA-cleared single-patient use, continuously recording ECG monitor that can be worn up to 14 days.




Primary Outcome Measures :
  1. Accuracy of AF detection - Sensitivity [ Time Frame: 14 days ]
    Accuracy of AF detection based on sensitivity observed in a 14-day followup period

  2. Accuracy of AF detection - Specificity [ Time Frame: 14 days ]
    Accuracy of AF detection based on specificity observed in a 14-day followup period


Secondary Outcome Measures :
  1. A sensitivity analysis estimating the range of sensitivities [ Time Frame: 14 days ]
    A sensitivity analysis estimating the range of sensitivities when imputing insufficient quality data

  2. A sensitivity analysis estimating the range of specificities [ Time Frame: 14 days ]
    A sensitivity analysis estimating the range of specificities when imputing insufficient quality data

  3. Estimates of sensitivity by protocol-defined subgroups [ Time Frame: 14 days ]
    Estimates of sensitivity by protocol-defined subgroups

  4. Estimates of specificity in subgroups [ Time Frame: 14 days ]
    Estimates of specificity in subgroups defined by: race, age-groups, site, activity levels, and AF-burden

  5. Estimates of positive predictive value (PPV) on the AF-burden [ Time Frame: 14 days ]
    Estimates of PPV based on the AF-burden observed in the study

  6. Estimates of negative predictive value (NPV) on the AF-burden [ Time Frame: 14 days ]
    Estimates of NPV based on the AF-burden observed in the study

  7. Estimates of PPV on the AF burden to a screening population [ Time Frame: 14 days ]
    Estimates of PPV based on the AF burden relevant to a screening population

  8. Estimates of NPV on the AF burden to a screening population [ Time Frame: 14 days ]
    Estimates of NPV based on the AF burden relevant to a screening population



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF)
Criteria

Inclusion Criteria:

  • At least 22 years old
  • Able to read and speak English
  • Able and willing to sign written Informed Consent
  • Interest in participating in the study
  • At risk of having an AF event, as determined by having a diagnosis of paroxysmal AF (PAF) and meeting one of the following: (a) scheduled or to be scheduled to undergo AF ablation, (b) with implantable loop recorder (ILR), implantable cardioverter defibrillator (ICD), permanent pacemaker (PPM), holter monitor, or adhesive monitoring patch with documented AF burden of ≥25% in the 3 months prior to consent date, (c) CHA2DS2VASc ≥3, (d) Left atrial diameter ≥4.4 cm
  • Without significant limitation in ability to participate in the study, in the opinion of the investigator

Exclusion Criteria:

  • Currently in a paced rhythm
  • Currently on class Ic or class III antiarrhythmic medication that has been successful in eliminating AF (no documented AF of more than 30 seconds since the initiation of the medication)
  • Had successful AF ablation (no documented AF of more than 30 seconds post procedure)
  • Known severe allergy to nickel or metal jewelry
  • Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies
  • Are diagnosed with persistent AF
  • Use of implantable neuro-stimulator
  • Open injury or rash where the study device or comparator will be worn

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): NCT04546763


Locations
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United States, California
San Diego Cardiac Center
San Diego, California, United States, 92123
United States, Colorado
Colorado Heart and Vascular
Lakewood, Colorado, United States, 80228
United States, Michigan
Ascension Providence Hospital
Southfield, Michigan, United States, 48075
United States, Pennsylvania
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, United States, 17011
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Verily Life Sciences LLC
Investigators
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Principal Investigator: Hamid Ghanbari Verily Life Sciences
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Responsible Party: Verily Life Sciences LLC
ClinicalTrials.gov Identifier: NCT04546763    
Other Study ID Numbers: 102238
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021

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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
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