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

Medical Devices Clinical Trial

Official title:

Validation of a High-Quality Low-Cost Open-Source Electrocardiograph (ECG)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04209062
• Other study ID #: 112365
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2022
• Source: Lawson Health Research Institute
• Contact: Tarek Loubani, MD
• Phone: 15196858500
• Email: tarek[@]tarek.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: July 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Electrocardiograph
• Low Cost
• Medical Devices
• Open Access

Intervention

Device:
• Medical device validation
The medical devices will both record electrical signals for comparison

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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