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Continuous Data Collection and Analysis for Stroke Prevention Using a Wearable Sensor

Primary Purpose

Atrial Fibrillation

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Amiigo Watch Only
Amiigo Watch + BodyGuardian
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Cardioversion, BodyGuardian, Amiigo Wristband

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female 18 years of age or older with a primary diagnosis of atrial fibrillation
  2. Willing and able to provide informed consent and follow the study protocol
  3. Clinically indicated planned restoration of normal rhythm

Exclusion Criteria:

  1. Unable to provide informed consent
  2. Unable to follow the study protocol
  3. Women who are pregnant
  4. Subjects with implantable devices (only if participating in phase 2-BodyGuardian processes/testing)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cardioversion

    Arm Description

    Amiigo watch during atrial fibrillation cardioversion. Optional sub-study: additional 30 days wearing Amiigo watch as well as BodyGuardian device.

    Outcomes

    Primary Outcome Measures

    Watch Accuracy during Cardioversion
    Determine whether the R-R interval estimate from artifact-free non-invasive photoplethysmography sample waveform segments is a reasonable basis for a atrial fibrillation (AF) detection algorithm as compared to a gold standard measurement from ECG in the acute cardioversion setting
    Watch Accuracy compared to BodyGuardian
    Determine the accuracy of ambulatory photoplethysmography for detection of heart rhythm when compared with a wearable clinically available 30 day monitor (BodyGuardian) in terms of accuracy of AF detection.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 15, 2018
    Last Updated
    September 7, 2021
    Sponsor
    Mayo Clinic
    Collaborators
    Koronis Biomedical Technologies, National Institute on Aging (NIA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03441022
    Brief Title
    Continuous Data Collection and Analysis for Stroke Prevention Using a Wearable Sensor
    Official Title
    Continuous Data Collection and Analysis for Stroke Prevention Using a Wearable Sensor
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Unable to obtain equipment from Sponsor to be able to proceed with the study.
    Study Start Date
    July 15, 2021 (Anticipated)
    Primary Completion Date
    August 2021 (Anticipated)
    Study Completion Date
    August 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic
    Collaborators
    Koronis Biomedical Technologies, National Institute on Aging (NIA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG).
    Detailed Description
    The purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG). These wristbands detect your pulse based on a technique called "photoplethysmography," (PPG). PPG is a common method in which an individual's pulse is detected based on a light signature interpreted by the wristband. Most commercially available heart rate monitors use PPG to determine your heart rate, but the accuracy is variable.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation
    Keywords
    Cardioversion, BodyGuardian, Amiigo Wristband

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cardioversion
    Arm Type
    Experimental
    Arm Description
    Amiigo watch during atrial fibrillation cardioversion. Optional sub-study: additional 30 days wearing Amiigo watch as well as BodyGuardian device.
    Intervention Type
    Device
    Intervention Name(s)
    Amiigo Watch Only
    Other Intervention Name(s)
    Cardioversion
    Intervention Description
    Subjects will be asked to wear a wrist band with capabilities to detect their heart rate or rhythm on the basis of PPG on either wrist around the time of their cardioversion procedure. Data will be acquired from the wrist band at the same time as the electrocardiogram (ECG) monitor to which subjects are hooked up for the purposes of the cardioversion.
    Intervention Type
    Device
    Intervention Name(s)
    Amiigo Watch + BodyGuardian
    Other Intervention Name(s)
    Cardioversion plus 30 days
    Intervention Description
    Subjects will be sent home after the cardioversion with a 30 day heart monitor called the BodyGuardian. This device continuously monitors their heart rate and rhythm and they will wear this on the chest. Subjects will also wear the wrist monitor over the same 30 day period.
    Primary Outcome Measure Information:
    Title
    Watch Accuracy during Cardioversion
    Description
    Determine whether the R-R interval estimate from artifact-free non-invasive photoplethysmography sample waveform segments is a reasonable basis for a atrial fibrillation (AF) detection algorithm as compared to a gold standard measurement from ECG in the acute cardioversion setting
    Time Frame
    Duration of cardioversion procedure
    Title
    Watch Accuracy compared to BodyGuardian
    Description
    Determine the accuracy of ambulatory photoplethysmography for detection of heart rhythm when compared with a wearable clinically available 30 day monitor (BodyGuardian) in terms of accuracy of AF detection.
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female 18 years of age or older with a primary diagnosis of atrial fibrillation Willing and able to provide informed consent and follow the study protocol Clinically indicated planned restoration of normal rhythm Exclusion Criteria: Unable to provide informed consent Unable to follow the study protocol Women who are pregnant Subjects with implantable devices (only if participating in phase 2-BodyGuardian processes/testing)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Suraj Kapa, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    https://www.mayo.edu/research/clinical-trials
    Description
    Mayo Clinic Clinical Trials

    Learn more about this trial

    Continuous Data Collection and Analysis for Stroke Prevention Using a Wearable Sensor

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