Cardiac Rhythm DisturbanceNCT05970328
Hexoskin Medical System - ECG Performance Testing
An observational study of Cardiac Rhythm Disturbance, run by Carré Technologies Inc. at 2 sites in Canada.
Trial summary
The goal of this observational study is to validate the efficacy of the Hexoskin Medical System (HMS) for its intended use (i.e., manual assessment of cardiac rhythm disturbances) in non-critical adult participants who are suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via… Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Cardiac Rhythm Disturbance
- What is being tested?
- Hexoskin Medical System
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 2 sitesCanada
- Study dates
- 24 Jul 2023to 17 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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients consulting the cardiology clinics
Who may be able to join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 21 years or older.
- Participants must be suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor.
Who cannot join
- Body circumference that is not covered by the HMS Shirt sizing chart
- Presence of pacemaker or Implantable Cardioverter-Defibrillator (ICD) devices
- Known allergic reactions to silver or polyamide/polyester/elastane
- Known allergic reactions to ECG gel electrodes
- Documented medical condition or illness requiring intensive medical treatment or care
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Yorkview Cardiology
North York
Lawrence Park Cardiology
Toronto, Ontario, M4N 3N1
About this study
Official title: HMS ECG Clinical Validation Study - Protocol External Site
The goal of this observational study is to validate the efficacy of the Hexoskin Medical System (HMS) for its intended use (i.e., manual assessment of cardiac rhythm disturbances) in non-critical adult participants who are suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor.
Read the detailed description
The main questions it aims to answer are:
- Whether the HMS ECG recordings can be used to accurately detect cardiac beats when compared with the Holter monitor
- Whether there are good agreements between the HMS and Holter monitor in ECG characteristics
- Whether the HMS ECG recordings can be used to accurately classify cardiac rhythm/rhythm disturbance when compared with the Holter monitor
- What is the accuracy of using HMS ECG recordings to detect cardiac beats
- What is the accuracy of using HMS ECG recordings to identify cardiac rhythm/rhythm disturbance
Participants will wear the HMS and the Holter monitor at the same time to record ECG signals. Researchers will evaluate the ECG recordings acquired from both devices and assess the above questions.
- Conditions
- Cardiac Rhythm Disturbance
- Being tested
- Hexoskin Medical System
- Keywords
- Hexoskin Medical System (HMS), Cardiac Rhythm Disturbance
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hexoskin Medical SystemDevice
Also called Nasiff Holter Monitor
Participant wears both the Hexoskin Medical System and the Nasiff Holter Monitor at the same time to acquire ECG recordings.
| Study group | Role | What they receive |
|---|---|---|
| Arrhythmia Participant | Non-critical adult (21 years and older) participants that are suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor. Receives: Device: Hexoskin Medical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG characteristics measurement agreement
The agreement (Bland-Altman plots) of Holter monitor(reference standard) and HMS to measure each of the four (4) ECG Characteristics. ECG characteristics measured in this study include: RR Interval (ms), PR Interval (ms), PP Interval (ms), and QRS Duration (ms).
Measured: 2 days
Secondary outcomes (1)
Heart rate agreement
The agreement between HR calculated from the recordings acquired by the subject device and the reference Holter monitor.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start24 Jul 2023
- Primary completion17 Feb 2024
- Study completion17 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Rhythm DisturbanceStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carré Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Cheung, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970328
- Sponsor's protocol ID
- HMSECG23
- Other IDs
- 361070
- Status last verified
- Aug 2024
- First submitted
- 21 Jul 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HMS ECG Clinical Validation Study - Protocol External Site
- ClinicalTrials.gov ID
- NCT05970328
- Acronym / sponsor ID
- HMSECG23
- Conditions
- Cardiac Rhythm Disturbance
- Keywords
- Hexoskin Medical System (HMS), Cardiac Rhythm Disturbance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Carré Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 17 Feb 2024 (actual)
- Study completion
- 17 Feb 2024 (actual)
- First posted
- 1 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 validate the efficacy of the Hexoskin Medical System (HMS) for its intended use (i.e., manual assessment of cardiac rhythm disturbances) in non-critical adult participants who are suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor.
Detailed description
The main questions it aims to answer are:
- Whether the HMS ECG recordings can be used to accurately detect cardiac beats when compared with the Holter monitor
- Whether there are good agreements between the HMS and Holter monitor in ECG characteristics
- Whether the HMS ECG recordings can be used to accurately classify cardiac rhythm/rhythm disturbance when compared with the Holter monitor
- What is the accuracy of using HMS ECG recordings to detect cardiac beats
- What is the accuracy of using HMS ECG recordings to identify cardiac rhythm/rhythm disturbance
Participants will wear the HMS and the Holter monitor at the same time to record ECG signals. Researchers will evaluate the ECG recordings acquired from both devices and assess the above questions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arrhythmia Participant | – | Device: Hexoskin Medical SystemNon-critical adult (21 years and older) participants that are suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients consulting the cardiology clinics
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, aged 21 years or older.
- Participants must be suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor.
Key exclusion criteria (5 listed)
- Body circumference that is not covered by the HMS Shirt sizing chart
- Presence of pacemaker or Implantable Cardioverter-Defibrillator (ICD) devices
- Known allergic reactions to silver or polyamide/polyester/elastane
- Known allergic reactions to ECG gel electrodes
- Documented medical condition or illness requiring intensive medical treatment or care
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 |
|---|---|---|
| Hexoskin Medical SystemAlso: Nasiff Holter MonitorParticipant wears both the Hexoskin Medical System and the Nasiff Holter Monitor at the same time to acquire ECG recordings. | Device | Arrhythmia Participant |
Primary outcome
ECG characteristics measurement agreement
Time frame: 2 days
The agreement (Bland-Altman plots) of Holter monitor(reference standard) and HMS to measure each of the four (4) ECG Characteristics. ECG characteristics measured in this study include: RR Interval (ms), PR Interval (ms), PP Interval (ms), and QRS Duration (ms).
1 secondary outcome
Heart rate agreement
Time frame: 2 days
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 21 Aug 2024.
- Individual participant dataSharing planned: No. There is no plan to make IPD available.
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.
Christopher Cheung, MD principal investigator
Sunnybrook Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Rhythm Disturbance, run by Carré Technologies Inc. at 2 sites 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 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: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
ECG characteristics measurement agreement (time frame: 2 days). 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 21 Aug 2024; AzTrials last refreshed its copy on 28 Oct 2026.