Cardiac ArrhythmiaNCT05983484
Holter Versus Skiin Garments
An observational study of Cardiac Arrhythmia, run by Myant Medical Corp. at 1 site in Canada.
Trial summary
The goal of this observational study is to compare the electrocardiogram recording from Holter monitor with textile sensors (in the form of clothing) in patients diagnosed with arrhythmia. 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?
- Skiin Underwear
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 1 siteCanada
- Study dates
- 16 Oct 2023to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: adults with cardiovascular disease and/or risks justifying the need for performing an ECG Holter
Who may be able to join
- Being addressed to the PACE cardiology clinic to perform an ECG due to a diagnosed or suspected cardiovascular disease.
- Age above 18
- Understand and speak English enough to consent and answer the study questionnaire.
- A medical need for Holter monitoring, and having a personal smartphone (iOS or Android), compatible with the Skiin app (application used to monitor the patient using the wearable device)
Who cannot join
- Pregnancy
- Implanted defibrillator or pacemaker
- Absence of garment fitting the participant's body
- Open wound or dressing (e.g. band-aid) on a body part that needs to be in contact with the Skiin electrodes
- Severe frailty such that donning or doffing the garment may cause a danger of fall.
- Sensitive skin
Trial locations and contacts
1 site in 1 country.
Canada1 site
Partners in Advanced Cardiac Evaluation (PACE) clinic
Newmarket, Ontario, L3Y 2P6
About this study
Official title: Non-Invasive Monitoring of Arrhythmias Electrocardiogram (ECG) Using Textile Sensors (MYANT)
The goal of this observational study is to compare the electrocardiogram recording from Holter monitor with textile sensors (in the form of clothing) in patients diagnosed with arrhythmia. The study aims to answer the following questions:
- Can the textile sensors provide continuous monitoring and detect arrhythmias?
- Do patients prefer to wear textile sensors instead of the Holter?
Participants that need Holter monitoring as part of their standard care will be invited to participate in the study. They will simultaneously wear both, the Holter monitor and the textile sensors for the time prescribed by their physician. Participants will also be asked to answer a questionnaire in the initial assessment and at the end of the study.
- Conditions
- Cardiac Arrhythmia
- Being tested
- Skiin Underwear
- Keywords
- ECG, Wearable, Holter
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skiin UnderwearDevice
Also called PocketECG
All participants enrolled will wear simultaneously the PocketECG (Standard Holter) and the Skiin Underwear Chestband (wearable textile). Each participant will wear both systems for the duration prescribed by their physician (1 to 14 days).
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Usable ECG
The duration of diagnostic ECG from PocketECG minus the duration of diagnostic ECG from Skiin underwear
Measured: Throughout the entire data collection period, that is between 1 and 14 days
Difference in Heart Rate
The heart rate obtained from PocketECG minus the heart rate obtained from Skiin underwear
Measured: Throughout the entire data collection period, that is between 1 and 14 days
Difference in RR intervals
The RR intervals obtained from PocketECG minus the RR intervals obtained from Skiin underwear
Measured: Throughout the entire data collection period, that is between 1 and 14 days
Arrhythmic events
The number and proportion of arrhythmic events obtained by PocketECG and by Skiin underwear
Measured: Throughout the entire data collection period, that is between 1 and 14 days
Secondary outcomes (1)
Patient's perception
A questionnaire developed by Myant containing 10 questions related to the comfort, usability, ease of use and enjoyment will be applied to assess patients' perception of the Skiin underwear and of the PocketECG and to compare both systems, with answers on a 7 point Lickert Scale (from Strongly disagree to Strongly Agree, no numeric scoring).
Measured: At the end of the study, 1 to 14 days after initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start16 Oct 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myant Medical Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Partners in Advanced Cardiac Evaluation
- Responsible party
- Sponsor
- Investigators
- Yaariv Khaykin, MD, Principal investigator, Partners in Advanced Cardiac Evaluation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983484
- Sponsor's protocol ID
- MYANT/PACE - 073-1819-7
- Status last verified
- Feb 2024
- First submitted
- 23 May 2023
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Monitoring of Arrhythmias Electrocardiogram (ECG) Using Textile Sensors (MYANT)
- ClinicalTrials.gov ID
- NCT05983484
- Acronym / sponsor ID
- MYANT/PACE - 073-1819-7
- Conditions
- Cardiac Arrhythmia
- Keywords
- ECG, Wearable, Holter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Myant Medical Corp.Industry (pharma, biotech, devices)
- Collaborators
- Partners in Advanced Cardiac Evaluation
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 9 Aug 2023 (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.
The goal of this observational study is to compare the electrocardiogram recording from Holter monitor with textile sensors (in the form of clothing) in patients diagnosed with arrhythmia. The study aims to answer the following questions:
- Can the textile sensors provide continuous monitoring and detect arrhythmias?
- Do patients prefer to wear textile sensors instead of the Holter?
Participants that need Holter monitoring as part of their standard care will be invited to participate in the study. They will simultaneously wear both, the Holter monitor and the textile sensors for the time prescribed by their physician. Participants will also be asked to answer a questionnaire in the initial assessment and at the end of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults with cardiovascular disease and/or risks justifying the need for performing an ECG Holter
Key inclusion criteria (4 listed)
- Being addressed to the PACE cardiology clinic to perform an ECG due to a diagnosed or suspected cardiovascular disease.
- Age above 18
- Understand and speak English enough to consent and answer the study questionnaire.
- A medical need for Holter monitoring, and having a personal smartphone (iOS or Android), compatible with the Skiin app (application used to monitor the patient using the wearable device)
Key exclusion criteria (6 listed)
- Pregnancy
- Implanted defibrillator or pacemaker
- Absence of garment fitting the participant's body
- Open wound or dressing (e.g. band-aid) on a body part that needs to be in contact with the Skiin electrodes
- Severe frailty such that donning or doffing the garment may cause a danger of fall.
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 |
|---|---|---|
| Skiin UnderwearAlso: PocketECGAll participants enrolled will wear simultaneously the PocketECG (Standard Holter) and the Skiin Underwear Chestband (wearable textile). Each participant will wear both systems for the duration prescribed by their physician (1 to 14 days). | Device | – |
Primary outcome
Difference in Usable ECG
Time frame: Throughout the entire data collection period, that is between 1 and 14 days
The duration of diagnostic ECG from PocketECG minus the duration of diagnostic ECG from Skiin underwear
Difference in Heart Rate
Time frame: Throughout the entire data collection period, that is between 1 and 14 days
The heart rate obtained from PocketECG minus the heart rate obtained from Skiin underwear
Difference in RR intervals
Time frame: Throughout the entire data collection period, that is between 1 and 14 days
The RR intervals obtained from PocketECG minus the RR intervals obtained from Skiin underwear
Arrhythmic events
Time frame: Throughout the entire data collection period, that is between 1 and 14 days
The number and proportion of arrhythmic events obtained by PocketECG and by Skiin underwear
1 secondary outcome
Patient's perception
Time frame: At the end of the study, 1 to 14 days after initiation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Yaariv Khaykin, MD principal investigator
Partners in Advanced Cardiac Evaluation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 26 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Usable ECG (time frame: Throughout the entire data collection period, that is between 1 and 14 days). The study lists 4 primary outcomes in all. 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 26 Feb 2024.