Smart Textile ECG Monitoring

April 14, 2025 updated by: Myant Medical Corp.

Non-Invasive Ambulatory Monitoring of Electrocardiogram (ECG) and Arrhythmia Detection Using Textile Electrodes

This research is a clinical evaluation of the Skiin chest band, a smart garment with embedded electronic textile (e-textile) electrodes, to record body surface electrocardiogram (ECG) signals. Developed by Myant Textile Computing Inc., the Skiin chest band (i.e. as part of the Skiin Underwear family of garments) is a component of the Myant Health Platform (MHP). The MHP also consists of: (a) a mobile phone application (Skiin Connected Life Application; SCLA), and (b) the Myant Virtual Clinic Portal (MVCP). In this study, participants will wear the Skiin chest band to collect their ECG for a period of 14 days. Participants will also be provided with a smartphone that is pre-loaded with the SCLA to record any symptoms (e.g. palpitations, shortness of breath, fatigue, light- headedness, fainting, etc.) they may experience over the 14 day ECG monitoring period. The data collected in this study will be used to develop new algorithms and patient monitoring tools to detect and predict cardiovascular health problems.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P4
        • Recruiting
        • Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic
        • Contact:
          • Mouhannad Sadek, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being referred to the Partners in Advanced Cardiac Evaluation (PACE Cardiology), and having been prescribed a 14-day ambulatory ECG monitoring by their physician.
  • Able to understand and speak English language, enough to provide informed consent.

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Cardiovascular Implantable Electronic Devices (CIED), including Implanted cardioverter defibrillator (ICD) or pacemakers
  • Absence of chest band that fits the participant's body
  • Open wound or dressing on a body part that needs to be in contact with the Skiin garment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adults with cardiovascular disease and/or risk factors
In this study, a total of 300 participants are expected to participate, specifically: The target population for this study are adults above 18 years of age with cardiovascular disease and/or risk factors, who have been prescribed a 14-day ambulatory ECG monitoring by their physician.
Device: Electronic-Textile-based Electrocardiographic Monitoring
Participants will be invited to wear the Skiin chest band for up to 14 days, as prescribed by their physician. Participants will wear the Skiin chest band in a similar capacity to a conventional Holter monitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arrhythmia Detection
Time Frame: Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.
To evaluate the performance of Skiin chest band in collecting ambulatory body surface ECG, and in detecting the presence or absence of arrhythmias for up to 14 days
Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Algorithm Validation (Arrhythmia detection)
Time Frame: Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.
To validate an artificial intelligence/ machine learning (AI/ML) arrhythmia detection algorithm
Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.
Algorithm Validation (Atrial Fibrillation Burden)
Time Frame: Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.
To use the AI/ML arrhythmia detection algorithm to establish Atrial Fibrillation burden, defined as: the ratio of time spent in Atrial Fibrillation over total monitoring duration (i.e. up to 14 days)
Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.
Clinic Workflow Statistics
Time Frame: Before and after ambulatory ECG monitoring (up to 14 days) for each patient
To document workflow statistics for Skiin ambulatory ECG monitoring in terms of (a) patient set-up s (i.e. the time it takes (in minutes) to set up a patient with the Skiin, and (b) report processing time (i.e. the time it takes for the ECG technician to scan/process the ambulatory ECG results?
Before and after ambulatory ECG monitoring (up to 14 days) for each patient
Usability Rating
Time Frame: Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.

To evaluate the usability of the Skiin chest band for ambulatory ECG monitoring, as rated by study participants on the associated usability questionnaire. The questionnaire, entitled "Smart Textile ECG Monitoring (PACE-MYANT) - Usability Questionnaire". The questionnaire includes 16 questions that are answered on a 7-point Likert scale, in addition to other questions, where participants.

The ratings in the the 7-point Likert scale (sections A) are "Strongly Disagree", "Disagree", Somewhat Disagree", "Neither agree nor disagree", "Somewhat Agree", "Agree", "Strongly Agree". Higher ratings and scores indicate better usability and overall experience.

The ratings in the sections C are from 1 to 7: "Strongly favor other Holter", "Favor other Holter", "Somewhat Favor other Holter", "No preference", "Somewhat favor Skiin", "Favor Skiin", "Strongly favor Skiin". Higher ratings and scores indicate preference for Skiin vs. standard Holter monitoring with wires and adhesive patches.
Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myant Medical Corp.

Collaborators

Partners in Advanced Cardiac Evaluation

Investigators

  • Principal Investigator: Mouhannad Sadek, MD, Partners in Advanced Cardiac Evaluation (PACE)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2025

Primary Completion (Estimated)

February 19, 2026

Study Completion (Estimated)

February 19, 2026

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5.21

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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