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

NCT03441022 — Not applicable, Withdrawn, Mayo Clinic

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Registry	NCT03441022
Status	Withdrawn - Unable to obtain equipment from Sponsor to be able to proceed with the study.
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, prevention
Sponsor	Mayo Clinic (Other); collaborators: Koronis Biomedical Technologies, National Institute on Aging (NIA)
Conditions	Atrial Fibrillation
Interventions	Amiigo Watch Only, Amiigo Watch + BodyGuardian (Device)
Dates	start 2021-07-15 (estimated), primary completion 2021-08-01 (estimated), completion 2021-08-01 (estimated), first posted 2018-02-22, last updated 2021-09-14

-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).

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Cardioversion	Experimental	Device: Amiigo Watch Only; Device: Amiigo Watch + BodyGuardian	Amiigo watch during atrial fibrillation cardioversion. Optional sub-study: additional 30 days wearing Amiigo watch as well as BodyGuardian device.

Amiigo Watch Only (Device), also known as Cardioversion: 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.
Amiigo Watch + BodyGuardian (Device), also known as Cardioversion plus 30 days: 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.

+Outcome measures

Primary outcomes

Watch Accuracy during Cardioversion [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
Watch Accuracy compared to BodyGuardian [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

Sex: All, ages: 18 Years to any

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)

+Investigators

Suraj Kapa, MD, Principal investigator, Mayo Clinic

+Funding

NIH grants: R43AG058516

My Notes

Public

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