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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smart garment, the Skiin chest band, designed to monitor heart activity and detect potential heart problems. Participants will wear this band for 14 days to record their ECG (a test that checks the heart's electrical activity) and note any symptoms, such as feeling faint or experiencing heart palpitations, through a smartphone app. The goal is to develop new methods to predict and monitor heart health issues. Ideal participants are adults advised by their doctor to undergo a 14-day heart monitoring test and have some heart disease or risk factors. As an unphased trial, this study offers participants the chance to contribute to innovative heart health monitoring solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on monitoring heart activity with a wearable device, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that the Skiin chest band is safe for ECG monitoring?

Research has shown that electronic textile (e-textile) systems, such as the Skiin chest band, provide comfort for health monitoring. Studies have found that these smart garments effectively record heart signals (ECG) with minimal discomfort or side effects. E-textiles offer a promising alternative to traditional methods, providing a more comfortable experience. Although specific side effects are not well-documented, wearable technology for ECG monitoring has generally proven safe. Participants in earlier studies using these smart garments did not report major safety concerns, suggesting that the Skiin chest band is likely safe for monitoring heart rhythms in daily life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about electronic-textile-based ECG monitoring for arrhythmia because it offers a unique and convenient way to track heart health. Unlike traditional Holter monitors, which can be bulky and uncomfortable, this smart textile is lightweight and can be worn as clothing, making it easier for patients to go about their daily activities. It continuously records heart activity over 14 days, providing detailed data that can help catch irregular heartbeats more effectively. This innovation could lead to earlier detection and treatment of cardiovascular issues, improving patient outcomes and comfort.

What evidence suggests that this smart textile ECG monitoring is effective for arrhythmia?

Research shows that electronic-textile-based ECG monitors, such as the Skiin chest band, are promising tools for tracking heart health. In this trial, participants will use these smart fabrics to monitor their heart conditions. Studies have found that these devices accurately detect irregular heartbeats, such as atrial fibrillation. The data collected is sufficient for monitoring heart conditions outside of a hospital. These monitors are comfortable and easy to wear daily, encouraging long-term use. This could help doctors detect heart problems early and manage them more effectively. ^{1 3 6 7 8}

Who Is on the Research Team?

Mouhannad Sadek, MD

Principal Investigator

Partners in Advanced Cardiac Evaluation (PACE)

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06870175?term=e+textiles&rank=2

Study Details | NCT06870175 | Smart Textile ECG Monitoring The data collected in this study will be used to develop new algorithms and patient monitoring tools to detect and predict cardiovascular health problems.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8234162/

Wearable Smart Textiles for Long-Term ... This review assesses the application of textile electrodes for ECG monitoring from the fundamentals to the latest developments and prospects for their future ...

3. mdpi.com mdpi.com/1424-8220/25/3/676

Smart Textile ECG Wearables for Comfort, Integration ... This review evaluates textile-based ECG devices by comparing their performance—assessed through AF detection rates, signal-to-noise ratio (SNR) and total ...

4. researchgate.net researchgate.net/publication/336661954_Electronic_textile-based_electrocardiogram_monitoring_in_cardiac_patients_a_scoping_review

Electronic textile-based electrocardiogram monitoring in ... Introduction: E-textile-based ECG monitoring of cardiac patients offers a possible new alternative for in-hospital monitoring and post-discharge monitoring ...

5. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2021.806726/full

Preliminary Analysis of a Wireless and Wearable Electronic ... This study aimed to determine whether signals produced by an e-textile ECG monitor with textile electrodes in an EASI configuration are of sufficient quality.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31633636/

Electronic textile-based electrocardiogram monitoring in ... Introduction: E-textile-based ECG monitoring of cardiac patients offers a possible new alternative for in-hospital monitoring and post-discharge monitoring ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/00405175221108208

Electronic textiles for electrocardiogram monitoring E-textile-based systems for health monitoring have focused on sensor materials embedded in clothing to record biological signals or vital signs ...

8. nursingcenter.com nursingcenter.com/journalarticle?Article_ID=4908830&Journal_ID=3425880&Issue_ID=4908597

Electronic textile electrocardiogram monitoring in cardiac ... The focus of this scoping review is on the use of e-textiles for ECG monitoring in cardiac patients. Cardiovascular disease refers to a group of disorders of ...