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

Study Overview
=================
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.

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

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Amiigo Watch Only
* Device: Amiigo Watch + BodyGuardian


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardioversion<br>Amiigo watch during atrial fibrillation cardioversion. Optional sub-study: additional 30 days wearing Amiigo watch as well as BodyGuardian device. | Device: Amiigo Watch Only<br>* 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.<br>* Other names: Cardioversion;Device: Amiigo Watch + BodyGuardian<br>* 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.<br>* Other names: Cardioversion plus 30 days;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardioversion, BodyGuardian, Amiigo Wristband