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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04209062

Enrollment

450

Registered

2019-12-23

Start date

2023-01-01

Completion date

2024-07-01

Last updated

2022-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electrocardiograph, Low Cost, Medical Devices, Open Access

Keywords

Open Access, Medical Devices, Low Cost

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.

Interventions

DEVICEMedical device validation

The medical devices will both record electrical signals for comparison

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Equivalence of Electrical Signals between 3D printed ECG device and Gold Standard ECG	60 seconds	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.

Countries

Canada

Contacts

Primary ContactTarek Loubani, MD

tarek@tarek.org15196858500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026