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

Mayo Clinic

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Conditions

Atrial Fibrillation

Interventions

Amiigo Watch OnlyDEVICE

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 + BodyGuardianDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Time frame: Duration of cardioversion procedure

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.

Time frame: 30 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.