Clinical trial NCT06870175: Smart Textile ECG Monitoring
Official title: Non-Invasive Ambulatory Monitoring of Electrocardiogram (ECG) and Arrhythmia Detection Using Textile Electrodes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Arrhythmia
Keywords: Smart Textile
Ambulatory Electrocardiogram Monitoring
Holter Monitoring
Arrhythmia detection
Textile electrodes
Lead sponsor: Myant Medical Corp.
Sponsor class: INDUSTRY
Collaborators: name: Partners in Advanced Cardiac Evaluation
First posted: 2025-03-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Arrhythmia Detection
timeFrame: Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.
Secondary outcomes:
Other outcomes:
measure: Algorithm Validation (Arrhythmia detection)
timeFrame: Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.
measure: Algorithm Validation (Atrial Fibrillation Burden)
timeFrame: Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.
measure: Usability Rating
timeFrame: Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.
measure: Clinic Workflow Statistics
timeFrame: Before and after ambulatory ECG monitoring (up to 14 days) for each patient
Locations:
city: Newmarket
country: Canada
facility: Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic
state: Ontario
Study officials:
affiliation: Partners in Advanced Cardiac Evaluation (PACE)
name: Mouhannad Sadek, MD
role: PRINCIPAL_INVESTIGATOR
References: