Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch

Study Overview
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Brief Summary
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Heart rhythm disorders are common and significantly impact the lives of those affected and their families. The main problems can be categorized as: a) atrial fibrillation or AF and atrial flutter, b) supra-ventricular tachycardia or SVT, c) excessively slow heart beats (i.e., bradycardia or pauses) and d) ventricular arrhythmias. These problems can be difficult to detect with currently available monitoring options as they are all worn for shorter terms or are an invasive implantable option. The HeartWatch is a longer term monitoring system that is worn on the upper arm, allows users to create a tag and pairs with an app on a smartphone allowing for correlation of symptoms.

Detailed Description
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Patients who are being referred to wear a holter monitor or a Sirona event recorder will e approached to wear a HeartWatch simultaneously. This will allow collection of signals on both devices and to compare the accuracy of signals between the Heartwatch vs Holter monitor and the HeartWatch vs Sirona recorder. It will also examine the reliability of autodetect algorythms between the devices. We will also collect information to compare the amount of adverse events between the various systems and the patient preference of those systems.

Official Title
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Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch

Conditions
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Cardiac Arrhythmia, Diagnostic and Monitoring Cardiovascular Devices Associated With Adverse Incidents

Intervention / Treatment
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* Device: HeartWatch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 22 years of age at time of consent Clinically indicated for an ambulatory Event Recorder or Holter monitor test Able to follow the protocol No functional implantable pacemaker or defibrillator Left bicep circumference > 22 cm and < 45 cm Provision of written-informed consent Exclusion Criteria: Known allergy to any component of the Event Recorder Known allergy to any component of the Holter monitor Known allergy to any component of the HeartWatch Dextrocardia Implanted functional Pacemaker or Defibrillator Left bicep circumference < 22 cm Left bicep circumference < 45 cm

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will wear the Holter monitor and the HeartWatch or the Sirona event recorder and the HeartWatch
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Active device engagement<br>All subjects will wear either the Holter monitor and the HeartWatch or the Sirona event recorder and the HeartWatch | Device: HeartWatch<br>* The HeartWatch is indicated for the extended diagnostic evaluation of patients with symptomatic and transient symptoms such as light-headedness, syncope, and palpitations, as well as patients at risk for arrhythmias, but without significant symptoms. It is an armband consisting of the main body of the device with an additional sensor located on the band. It is worn around the upper left arm to obtain heart electrical signals. The device is paired with the HelpWear application on a smartphone where the signals are stored and then will be uploaded to a secure network for analysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QRS signal detection | The proportion of QRS complexes detected by the Holter lead I reference signal which are also successfully detected by the HeartWatch will be computed separately for each patient; | For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event classification | All patient-tagged (symptomatic) events (all devices) and all non-normal clinically significant rhythm auto-triggered events (HeartWatch and Event Recorder) and recorded events (HeartWatch and Holter). ECG data will be adjudicated and classified using literature-based definitions. Non-interpretable ECG recordings will be classified as incorrect for an event if an interpretable categorization is obtained from one of the comparator devices. | For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours), and for the initial 48 hours of the Sirona vs the HeartWatch. |