Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial

Study Overview
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Brief Summary
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The clinical study is intended to implement and test the collection and analysis of paired ECG data from the HeartWatch and two comparator devices, an Event Recorder and Holter. The HeartWatch is indicated for extended diagnostic evaluation of patients with transient symptoms of possible cardiac origin such as syncope and palpitations, as well as patients at risk for arrhythmias, but without significant symptoms. While the use of the device itself can be managed by both healthcare professionals and patients, interpretation of the collected data for diagnosis is restricted to healthcare professionals, as the data must be loaded and analyzed separately after recording. Patients indicated for extended ambulatory ECG testing will be approached for participation. Subjects will wear the HeartWatch and an Event Recorder for up to 72 hours or the HeartWatch and Holter monitor for up to 48 hours. Subjects will be asked to document their activities (standing, sitting, walking, exercise, or laying down). Event recorder subjects will collect user-triggered and auto-triggered data, while Holter subjects will record diary information on their activities and any relevant symptoms. Adverse events and user preference for one device versus the other being used in that arm will also be collected from all subjects. Paired ECG data from the HeartWatch and comparator devices is expected to be similar in terms of the events documented and the proportion of data that is clinically interpretable.

Official Title
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Preliminary Research Evaluation for Ambulatory Leadless Electrocardiogram Recorder Trial

Conditions
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Atrial Fibrillation, Tachycardia, Supraventricular, Bradyarrhythmia, Ventricular Arrythmia

Intervention / Treatment
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* Device: HeartWatch
* Device: Event Recorder
* Device: Holter Monitor


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 Able to follow the protocol 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

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm A<br>Up to 40 patients will be enrolled in Arm A. Subjects will wear the HeartWatch and an Event Recorder for up to 72 hours. Subjects will be asked to document their activities (standing, sitting, walking, exercise, or laying down). Event recorder subjects will collect user-triggered and auto-triggered data. | Device: HeartWatch<br>* The HeartWatch arm band provides continuous, high-quality single lead electrocardiograph (ECG) data in a variety of environments. The ECG data is transmitted via Bluetooth and stored on the user's smartphone. It is then uploaded to the cloud for subsequent analysis using either a commercial ECG software package or a customized software package from HelpWear.<br>Device: Event Recorder<br>* A standard 1 or 2-lead Sirona Event Recorder will be used to collect high-resolution data. Subjects will be asked to wear the clinical monitor for at least 48 hours and no longer than 84 hours. ECG signals will be continuously collected as long as the skin patches are attached to the skin and the recorder is properly connected to the wires.<br>|
| Arm B<br>Up to 10 patients will be enrolled in Arm B.Subjects will wear the HeartWatch and Holter monitor for up to 48 hours. Subjects will be asked to document their activities (standing, sitting, walking, exercise, or laying down). Holter subjects will record diary information on their activities and any relevant symptoms. | Device: HeartWatch<br>* The HeartWatch arm band provides continuous, high-quality single lead electrocardiograph (ECG) data in a variety of environments. The ECG data is transmitted via Bluetooth and stored on the user's smartphone. It is then uploaded to the cloud for subsequent analysis using either a commercial ECG software package or a customized software package from HelpWear.<br>Device: Holter Monitor<br>* A standard 5-lead SEER Holter will be used to collect 3-channels of high-resolution data. Subjects will be asked to wear the clinical, conventional monitor for at least 36 hours and no longer than 60 hours. During this time ECG signals will be continuously collected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pairing HeartWatch and Event Recorder | Can paired user-triggered (tagged) and auto-triggered ECG data from the HeartWatch and Event Recorder be successfully collected? | Up to 6 months, with 3 months of analysis time (9 months total) | 
| Pairing HeartWatch and Holter | Can paired continuous ECG data from the HeartWatch and Holter monitor be successfully collected? | Up to 6 months, with 3 months of analysis time (9 months total) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Position and Activity | Does body position and activity affect the quality of the HeartWatch, Event Recorder, and Holter data? | Up to 6 months, with 3 months of analysis time (9 months total) |