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

NCT ID: NCT04209062

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-07-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study device

Group Type: EXPERIMENTAL

Medical device validation

Intervention Type: DEVICE

The medical devices will both record electrical signals for comparison

Control device

Group Type: ACTIVE_COMPARATOR

Medical device validation

Intervention Type: DEVICE

The medical devices will both record electrical signals for comparison

Interventions

Medical device validation

The medical devices will both record electrical signals for comparison

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Tarek Loubani, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

Central Contacts

Tarek Loubani, MD

Role: CONTACT

tarek@tarek.org

15196858500 ext. 54970

Other Identifiers

112365

Identifier Type: -

Identifier Source: org_study_id