Smart Textile ECG Monitoring

NCT06870175 | Recruiting

• 1 other identifier: 5.21
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Arrhythmia

Keywords

Smart Textile; Ambulatory Electrocardiogram Monitoring; Holter Monitoring; Arrhythmia detection; Textile electrodes

Outcome Measures

Primary Outcomes (1)

• Arrhythmia Detection

  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 Outcomes (4)

• Algorithm Validation (Arrhythmia detection)

  Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.

• Algorithm Validation (Atrial Fibrillation Burden)

  Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.

• Usability Rating

  Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.

Study Arms (1)

Adults with cardiovascular disease and/or risk factors

EXPERIMENTAL

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

Interventions

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.

Adults with cardiovascular disease and/or risk factors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Myant Medical Corp.: lead
• Partners in Advanced Cardiac Evaluation: collaborator

Study Sites (1)

Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic

Newmarket, Ontario, L3Y 2P4, Canada

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mouhannad Sadek, MD

  Partners in Advanced Cardiac Evaluation (PACE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: February 19, 2025
• Primary Completion: February 19, 2026
• Study Completion: February 19, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)