Validation of a High-Quality Low-Cost Open-Source Electrocardiograph

Lawson Health Research Institute

Status: Not yet enrolling

Conditions: Electrocardiograph; Low Cost; Open Access; Medical Devices

Treatments: Device: Medical device validation

Study type: Interventional

Funder types: Other

Identifiers

NCT04209062

112365

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All study participants must be able to provide written informed consent prior to study procedure. This study has 2 Phases.

Phase 1:

• Healthy
• > 18 years of age

Phase 2:

• > 18 years of age
• non critical patients presenting to the emergency department (Victoria Hospital and University Hospital) with cardiac complaint

Exclusion criteria

• < 18 years old
• Unable to consent

Phase 1:

• > 70 years of age
• Previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure)
• current status of non-sinus heart rhythm

Phase 2:

• Critical patients in the ED where consent would inappropriately delay investigations or treatment

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Study device

Experimental group

Treatment:

Device: Medical device validation

Control device

Active Comparator group

Treatment:

Device: Medical device validation