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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Medical Devices; Open Access; Low Cost; Electrocardiograph
• Intervention / Treatment: Device: Medical device validation

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tarek Loubani, MD; Phone Number: 54970 15196858500; Email: tarek@tarek.org

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control device	Device: Medical device validation; The medical devices will both record electrical signals for comparison
EXPERIMENTAL: Study device	Device: Medical device validation; The medical devices will both record electrical signals for comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2023
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): July 1, 2024

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (ACTUAL): December 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Medical Devices; Open Access; Low Cost
• Other Study ID Numbers: 112365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No