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NCT Number: NCT06870175

Smart Textile ECG Monitoring

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.

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Key information

Conditions

Cardiac Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic

Newmarket, Ontario, L3Y 2P4, Canada

Location status: Recruiting

Location contact

Jenny Gao-Kang

CONTACT

[email protected]

905-953-7917

Mouhannad Sadek, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic-Textile-based Electrocardiographic Monitoring

Device

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.

Primary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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)

  3. 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.

  4. 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?

Sponsors and collaborators

Lead sponsor

Myant Medical Corp.

Industry

Collaborators

  • Partners in Advanced Cardiac Evaluation

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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