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OpenTrials
Completed

NCT Number: NCT04546763

Study Watch AF Detection At Home

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.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Diego Cardiac Center, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study Watch

Device

The Study Watch is a miniaturized wearable device made with biocompatible contact materials containing various sensors capable of measuring physiological and environmental metrics.

Zio XT

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Verily Life Sciences LLC

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2020
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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