RecruitingNot ApplicableNCT06870175

Smart Textile ECG Monitoring

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

Sponsor

Myant Medical Corp.

Enrollment

300 participants

Start Date

Feb 19, 2025

Study Type

INTERVENTIONAL

Conditions

Cardiac Arrhythmia

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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 Criteria5

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

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Interventions

DEVICEElectronic-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.