ALERT

The purpose of this research study is to compare the heart rhythms collected by the HeartWatch to heart recordings collected by the standard of care clinical heart monitors. This study will examine if the HeartWatch’s ability to record ECG tracings is similar to traditional heart monitoring devices currently used in clinical care settings.

All patients who enroll in this study will receive their intended traditional heart monitoring device as part of the standard of care and a HeartWatch and study phone with the HelpWear app for comparison.

Your participation will involve:

• History. We will collect basic information related to your age, gender, details of your heart condition, why you are having your heart rhythm monitored and your medications. We will review your medical records to obtain any data that is not available at the time of study arm band testing.

• Study band. The HeartWatch collects ECG signals from a person’s arm, non-invasively. You will wear the study HeartWatch on your left arm for the same duration that you are wearing a clinical Heart monitor that you were prescribed by your physician. The HeartWatch collects continuous ECG signals from four (4) built-in electrodes and transmits the data to a communication device (e.g., smartphone), and then send that information to the cloud using the Android Operating System and Bluetooth.
  
  While you are wearing the HeartWatch you will be asked to record or tag symptoms you have (rapid heartbeats, fainting, dizziness, etc) and your activities to allow for subsequent review by the evaluator (physician or technician). This is completed by pressing a button on the HeartWatch or the study smartphone with the HelpWear app.

• Clinical Holter monitor or Event recorder. Per standard of care, the physician will determine which type of heart monitor is best suited to you (either a Holter monitor or an Event recorder). Patches will be placed on your skin to collect heart electrical information (ECG) for the monitor. This is a standard test used in assessing people with or at risk of heart disease in the cardiac clinic.

• Symptoms. We will ask that you record your symptoms during the monitoring period using the HelpWear app on the study smartphone and in the symptom diary for the Holter monitor and Event recorder as is standard for these clinical monitors.

• Exit interview/questionnaire. This visit will occur when you are returning your clinical heart monitor.  It will include returning the HeartWatch and the HelpWear phone.  It will also include questions and a brief questionnaire to collect your feedback about your experience with the two different devices and to help determine where possible improvements can be made.

After 2 days of monitoring by the HeartWatch, you are finished the study and you will return the study devices, the HeartWatch armband and HelpWear phone. You may still be required to wear the Holter monitor or the event recorder until the recording period is complete as part of your standard clinical care, this will be determined by your physician. When all recordings are complete, both the HeartWatch and your clinical heart monitoring system tracings will be evaluated, and your physician will be informed of the results.  You will then continue with standard clinical care with your physician.

• Adverse events.  We will ask you if you experienced any adverse events during the time when you were wearing the device and in the study.

HeartWatch Usage Risks:

While the HeartWatch is painless and non-invasive, participants may experience skin irritation from where it is in contact with their skin.

Ambulatory ECG Recording Risks:

Other clinical heart monitors (Holters and Event Recorders) are painless and non-invasive. They require the user to keep a log of activities and symptoms, remove and replace skin patches when they are worn for extended periods and carry a monitor (receiver) on their belt or other clothing. Users may experience skin irritation and discomfort from the patches (adhesive electrodes) on their skin that are required to record the electrical activity of the heart.

There are no direct benefits to you for participating in this research study.