Smart Textile ECG Monitoring for Arrhythmia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Myant Medical Corp.

Disqualifiers: Age < 18, Pregnancy, CIED, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 14 days

300 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Mouhannad Sadek, MD

Principal Investigator

Partners in Advanced Cardiac Evaluation (PACE)

Eligibility Criteria

This trial is for individuals with arrhythmia who are interested in testing a smart garment, the Skiin chest band, designed to monitor heart activity. Participants will wear this e-textile for two weeks and use a provided smartphone app to log any symptoms like palpitations or shortness of breath.

Inclusion Criteria

I've been referred to PACE Cardiology and prescribed a 14-day heart monitor.

Exclusion Criteria

Pregnancy

Cardiovascular Implantable Electronic Devices (CIED), including Implanted cardioverter defibrillator (ICD) or pacemakers

Absence of chest band that fits the participant's body

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants wear the Skiin chest band to collect ECG data and record symptoms using a smartphone application

14 days

1 visit (in-person) for device setup

Follow-up

Participants are monitored for safety and effectiveness after the ECG monitoring period

2-4 weeks

Treatment Details

Interventions

• Electronic-Textile-based Electrocardiographic Monitoring

Trial Overview The study tests the effectiveness of the Skiin chest band in recording ECG signals as part of Myant Health Platform. It aims to collect data over a 14-day period using this wearable technology along with an app and virtual clinic portal.

Participant Groups

Group I: Adults with cardiovascular disease and/or risk factors Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Myant Medical Corp.

Lead Sponsor

Trials

7

Recruited

750+

Partners in Advanced Cardiac Evaluation

Collaborator

Trials

2

Recruited

350+