Cardiac ArrhythmiaNCT06870175
Smart Textile ECG Monitoring
A study testing Electronic-Textile-based Electrocardiographic Monitoring in people with Cardiac Arrhythmia, run by Myant Medical Corp. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- Electronic-Textile-based Electrocardiographic Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 19 Feb 2025to 7 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic
Newmarket, Ontario, L3Y 2P4
Jenny Gao-Kang, 905-953-7917, myant@pace-cardiology.com
Mouhannad Sadek, MD
About this study
Official title: Non-Invasive Ambulatory Monitoring of Electrocardiogram (ECG) and Arrhythmia Detection Using Textile Electrodes
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.
- Conditions
- Cardiac Arrhythmia
- Being tested
- Electronic-Textile-based Electrocardiographic Monitoring
- Keywords
- Smart Textile, Ambulatory Electrocardiogram Monitoring, Holter Monitoring, Arrhythmia detection, Textile electrodes
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic-Textile-based Electrocardiographic MonitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Adults with cardiovascular disease and/or risk factors | Experimental | 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. Receives: Device: Electronic-Textile-based Electrocardiographic Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start19 Feb 2025
- Primary completion7 Sep 2027 (estimated)
- Study completion7 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myant Medical Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Partners in Advanced Cardiac Evaluation
- Responsible party
- Sponsor
- Investigators
- Mouhannad Sadek, MD, Principal investigator, Partners in Advanced Cardiac Evaluation (PACE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870175
- Sponsor's protocol ID
- 5.21
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Ambulatory Monitoring of Electrocardiogram (ECG) and Arrhythmia Detection Using Textile Electrodes
- ClinicalTrials.gov ID
- NCT06870175
- Acronym / sponsor ID
- 5.21
- Conditions
- Cardiac Arrhythmia
- Keywords
- Smart Textile, Ambulatory Electrocardiogram Monitoring, Holter Monitoring, Arrhythmia detection, Textile electrodes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Myant Medical Corp.Industry (pharma, biotech, devices)
- Collaborators
- Partners in Advanced Cardiac Evaluation
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 7 Sep 2027 (estimated)
- Study completion
- 7 Sep 2027 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with cardiovascular disease and/or risk factors | Experimental | Device: Electronic-Textile-based Electrocardiographic MonitoringIn 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic-Textile-based Electrocardiographic MonitoringParticipants 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. | Device | Adults with cardiovascular disease and/or risk factors |
Primary outcome
Arrhythmia Detection
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Partners in Advanced Cardiac Evaluation (PACE) Cardiology Clinic
Newmarket, Canada
Mouhannad Sadek, MD principal investigator
Partners in Advanced Cardiac Evaluation (PACE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic-Textile-based Electrocardiographic Monitoring in people with Cardiac Arrhythmia, run by Myant Medical Corp. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmia Detection (time frame: Each participant undergoes up to 14 day ambulatory ECG monitoring from the time of wearing the Skiin chest band.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.