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

NCT03441022 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-09-14

No results posted yet for this study

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).

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Koronis Biomedical Technologies

    collaborator INDUSTRY

  • National Institute on Aging (NIA)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Suraj Kapa, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-15
Primary Completion
2021-08-31
Completion
2021-08-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03441022 on ClinicalTrials.gov