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

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: NCT03441022
Recruitment Status : Withdrawn (Unable to obtain equipment from Sponsor to be able to proceed with the study.)
First Posted : February 22, 2018
Last Update Posted : September 14, 2021
Sponsor:
Collaborators:
Koronis Biomedical Technologies
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Suraj Kapa, Mayo Clinic

Study Description
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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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Amiigo Watch Only Device: Amiigo Watch + BodyGuardian Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Continuous Data Collection and Analysis for Stroke Prevention Using a Wearable Sensor
Estimated Study Start Date : July 15, 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cardioversion
Amiigo watch during atrial fibrillation cardioversion. Optional sub-study: additional 30 days wearing Amiigo watch as well as BodyGuardian device.
 Device: Amiigo Watch Only
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.
Other Name: Cardioversion

Device: Amiigo Watch + BodyGuardian
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.
Other Name: Cardioversion plus 30 days


Outcome Measures
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Primary Outcome Measures :
  1. Watch Accuracy during Cardioversion [ Time Frame: Duration of cardioversion procedure ]
    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

  2. Watch Accuracy compared to BodyGuardian [ Time Frame: 30 days ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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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): NCT03441022


Sponsors and Collaborators
Mayo Clinic
Koronis Biomedical Technologies
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Suraj Kapa, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Suraj Kapa, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03441022    
Other Study ID Numbers: 17-006346
1R43AG058516-01 ( U.S. NIH Grant/Contract )
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Suraj Kapa, Mayo Clinic:
Cardioversion
BodyGuardian
Amiigo Wristband
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes