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

NCT04209062 | Unknown

• 1 other identifier: 112365
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Open Access; Medical Devices; Low Cost; Electrocardiograph

Keywords

Open Access; Medical Devices; Low Cost

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Study device

EXPERIMENTAL

Device: Medical device validation

Control device

ACTIVE COMPARATOR

Device: Medical device validation

Interventions

Medical device validation DEVICE

The medical devices will both record electrical signals for comparison

Control device; Study device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Central Study Contacts

Tarek Loubani, MD

CONTACT

15196858500; tarek@tarek.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: December 23, 2019
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: July 1, 2024
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)