Cardiac Arrhythmia
Conditions
Keywords
Smart Textile, Ambulatory Electrocardiogram Monitoring, Holter Monitoring, Arrhythmia detection, Textile electrodes
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.
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.
Sponsors
Partners in Advanced Cardiac Evaluation
Myant Medical Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmia Detection | Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band. | To evaluate the performance of Skiin chest band in collecting ambulatory body surface ECG, and in detecting the presence or absence of arrhythmias for up to 14 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Algorithm Validation (Atrial Fibrillation Burden) | Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band. | To use the AI/ML arrhythmia detection algorithm to establish Atrial Fibrillation burden, defined as: the ratio of time spent in Atrial Fibrillation over total monitoring duration (i.e. up to 14 days) |
| Algorithm Validation (Arrhythmia detection) | Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band. | To validate an artificial intelligence/ machine learning (AI/ML) arrhythmia detection algorithm |
| Usability Rating | Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band. | To evaluate the usability of the Skiin chest band for ambulatory ECG monitoring, as rated by study participants on the associated usability questionnaire. The questionnaire, entitled Smart Textile ECG Monitoring (PACE-MYANT) - Usability Questionnaire. The questionnaire includes 16 questions that are answered on a 7-point Likert scale, in addition to other questions, where participants. The ratings in the the 7-point Likert scale (sections A) are Strongly Disagree, Disagree, Somewhat Disagree, Neither agree nor disagree, Somewhat Agree, Agree, Strongly Agree. Higher ratings and scores indicate better usability and overall experience. The ratings in the sections C are from 1 to 7: Strongly favor other Holter, Favor other Holter, Somewhat Favor other Holter, No preference, Somewhat favor Skiin, Favor Skiin, Strongly favor Skiin. Higher ratings and scores indicate preference for Skiin vs. standard Holter monitoring with wires and adhesive patches. |
| Clinic Workflow Statistics | Before and after ambulatory ECG monitoring (up to 14 days) for each patient | To document workflow statistics for Skiin ambulatory ECG monitoring in terms of (a) patient set-up s (i.e. the time it takes (in minutes) to set up a patient with the Skiin, and (b) report processing time (i.e. the time it takes for the ECG technician to scan/process the ambulatory ECG results? |
Countries
Canada
Outcome results
None listed