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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209062
Recruitment Status : Not yet recruiting
First Posted : December 23, 2019
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Tarek Loubani, MD, Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Open Access Medical Devices Low Cost Electrocardiograph Device: Medical device validation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of a High-Quality Low-Cost Open-Source Electrocardiograph (ECG)
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2023

Arm Intervention/treatment
Experimental: Study device Device: Medical device validation
The medical devices will both record electrical signals for comparison

Active Comparator: Control device Device: Medical device validation
The medical devices will both record electrical signals for comparison




Primary Outcome Measures :
  1. Equivalence of Electrical Signals between 3D printed ECG device and Gold Standard ECG [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209062


Contacts
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Contact: Tarek Loubani, MD 15196858500 ext 54970 tarek@tarek.org

Locations
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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
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Responsible Party: Tarek Loubani, MD, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04209062    
Other Study ID Numbers: 112365
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tarek Loubani, MD, Lawson Health Research Institute:
Open Access
Medical Devices
Low Cost