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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.
Patients who are being referred to wear a holter monitor will be 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. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active device engagement | Other | All subjects will wear either the Holter monitor and the HeartWatch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartWatch | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| QRS signal detection | Compare QRS detection accuracy with HeartWatch data vs. the Holter monitor lead I signal | For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| ECG strip evaluation | Compare the overall agreement of the HeartWatch vs. Holter data in providing interpretable ECG strips data for all symptomatic (patient tagged) events and all cardiologist-verified non-normal rhythms identified by cardiology technologists (Holter). | For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours). |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Evaluate and describe adverse events related to the use of the HeartWatch and Holter devices. | For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours). |
| User preference |
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Cowan | Contact | 4035600225 | kcowan@ucalgary.ca | |
| Owen Gillett | Contact | 647-994-4077 | owen.gillett@helpwear.ca |
| Name | Affiliation | Role |
|---|---|---|
| Russell Quinn, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre University of Calgary | Recruiting | Calgary | Alberta | T2N 4N1 | Canada |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D004194 | Disease |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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All subjects will wear the Holter monitor and the HeartWatch.
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| ECG PR interval assessment | Assess the comparability of paired, 10-minute averaged PR intervals measured from the HeartWatch vs. the Holter lead I reference signal. | For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours). |
| ECG QRS interval assessment | Assess the comparability of paired, 10-minute averaged QRS intervals measured from the HeartWatch vs. the Holter lead I reference signal. | For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours). |
| ECG interval assessment | Assess the comparability of paired, 10-minute averaged heart rate corrected QT (QTc) intervals measured from the HeartWatch vs. the Holter lead I reference signal. | For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours). |
Compare user preferences for the HeartWatch and Holter devices
| For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours). |
| ECG strip categorization | Compare ECG strip categorizations of the HeartWatch vs. the Holter. | For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours. |
| Future software validation | To use the ECG data signals collected to validate future software | Data obtained during the recordings will be used for future software validation for 5 years. |