Smart Textile ECG Monitoring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electronic-Textile-based Electrocardiographic Monitoring.
- Who it may be relevant to
- Registry conditions: Cardiac Arrhythmia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Non-Invasive Ambulatory Monitoring of Electrocardiogram (ECG) and Arrhythmia Detection Using Textile Electrodes
Overview
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.
Interventions
- Device 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 measures
- Arrhythmia Detection [Time frame: Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Canada · 1 center
- Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic — Newmarket
Identifiers
NCT: NCT06870175 · 5.21