Recruiting

ECG Monitoring

Sponsor:

Myant Medical Corp.

Code:

NCT06870175

Conditions

Cardiac Arrhythmia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electronic-Textile-based Electrocardiographic Monitoring

Study Details

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

Study ID

NCT06870175

Start date

Feb 19, 2025

Status verified date

Apr, 2025

Completion date

Feb 19, 2026

Anticipated

Primary completion date

Feb 19, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Adults with cardiovascular disease and/or risk factors

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.

Interventions

Electronic-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.

Primary outcome measure

  • Arrhythmia Detection [ Time Frame: Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band. ]

Central Contacts and Locations

Locations

Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic

Recruiting

Newmarket, Ontario, Canada, L3Y 2P4

Contacts

Jenny Gao-Kang

905-953-7917myant@pace-cardiology.com

Principal Investigator:

Mouhannad Sadek, MD

More Information

Sponsor

Myant Medical Corp.

Last update posted

Apr 17, 2025

Last verified

Apr, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Myant Medical Corp. on 2025-04-17.