Smart Textile ECG Monitoring

Not Applicable

Recruiting

• Conditions: Cardiac Arrhythmia

• Registration Number: NCT06870175
• Lead Sponsor: Myant Medical Corp.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-19
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-05
• Study First Posted: 2025-03-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-02-19
• Study Completion: 2026-02-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Arrhythmia Detection	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

Trial Locations

Locations (1)

Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic; 🇨🇦 Newmarket, Ontario, Canada