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The high price of electrocardiograph (ECG) devices - with most hospital-grade devices costing thousands of dollars - is one of the barriers to access of this vital technology. There is a shortage of ECG devices in underserved areas and the devices available on the market currently are not adequate to solve this problem. Our solution is a low-cost high-quality open-access ECG device. This study intends to validate the study ECG device in human patients by demonstrating equivalence between the study ECG device and a gold standard device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study device | Experimental |
| |
| Control device | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical device validation | Device | The medical devices will both record electrical signals for comparison |
|
| Measure | Description | Time Frame |
|---|---|---|
| Equivalence of Electrical Signals between 3D printed ECG device and Gold Standard ECG | Comparing electrical signals from ECG electrodes with tested device and gold standard device by collecting the following data from both devices: rate, QR interval, PR interval, QT interval, and rhythm. | 60 seconds |
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Inclusion Criteria:
- All study participants must be able to provide written informed consent prior to study procedure. This study has 2 Phases.
Phase 1:
Phase 2:
Exclusion Criteria:
Phase 1:
Phase 2:
- Critical patients in the ED where consent would inappropriately delay investigations or treatment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tarek Loubani, MD | Contact | 15196858500 | 54970 | tarek@tarek.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
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