Smart Textile ECG Monitoring

Myant Medical

Status: Enrolling

Conditions: Cardiac Arrhythmia

Treatments: Device: Electronic-Textile-based Electrocardiographic Monitoring

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06870175

5.21

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Adults with cardiovascular disease and/or risk factors

Experimental group

Description:

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.

Treatment:

Device: Electronic-Textile-based Electrocardiographic Monitoring