Health TrialsbyHealthPanel

Smart Textile ECG Monitoring

ConditionCardiac Arrhythmia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMyant Medical Corp.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Electronic-Textile-based Electrocardiographic Monitoring

    Device

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Adults with cardiovascular disease and/or risk factorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Arrhythmia Detection

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

Time frame
Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.

Secondary outcomes

Other outcomes

1

Algorithm Validation (Arrhythmia detection)

To validate an artificial intelligence/ machine learning (AI/ML) arrhythmia detection algorithm

Time frame
Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.
2

Algorithm Validation (Atrial Fibrillation Burden)

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)

Time frame
Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.
3

Usability Rating

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.

Time frame
Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.
4

Clinic Workflow Statistics

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?

Time frame
Before and after ambulatory ECG monitoring (up to 14 days) for each patient

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Myant Medical Corp.

Lead sponsor

Partners in Advanced Cardiac Evaluation

Collaborator

Source ClinicalTrials.gov
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