ECG MonitoringCLONENCT07624435
Conventional Lead Opposed to Novel ECG (CLONE)
An observational study of ECG Monitoring, run by HelpWear Inc. at 2 sites in Canada.
Trial summary
To blindly assess, beat-by-beat, standard ECG intervals (QRS intervals, PQ intervals, and P wave durations) of paired standard lead v4 with paired HeartWatch signals over 20 to 30 seconds of noise-free data. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- ECG Monitoring
- What is being tested?
- ECG signals collection
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- 18 Feb 2026to 1 Aug 2027
- Phase
- Observational
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers undergoing a conventional 12-lead ECG who agree to wear a HeartWatch and use a Kardia mobile device during that ECG recording.
Who may be able to join
- At least 22 years of age at time of the conventional ECG recording
- Willing to participate in the study
- Able to follow the protocol
Who cannot join
- Known allergy to the electrodes used for a conventional ECG
- Known allergy to any component of the HeartWatch
- Known allergy to any component of the Kardia system
- Inability to wear the HeartWatch on the left arm due to pre-existing medical condition (e.g., functional AV fistula in left arm, prior carcinoma with lymph node dissection or lymphedema, known blood clot or recurrent blood clots in left arm, chronic neuropathic pain in left arm, …)
- Dextrocardia
- Implanted functional Pacemaker of Defibrillator
- Left upper arm circumference < 22 cm or > 45 cm
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Calgary
Calgary, Alberta, T2N 1N4
University of Calgary
Calgary, Alberta, T2N 4N1
About this study
Official title: Conventional Lead Opposed to Novel ECG
To blindly assess, beat-by-beat, standard ECG intervals (QRS intervals, PQ intervals, and P wave durations) of paired standard lead v4 with paired HeartWatch signals over 20 to 30 seconds of noise-free data.
Read the detailed description
This proof-of-concept study will enroll volunteers undergoing serial conventional 12-lead ECG rhythm strips who agree to wear a HeartWatch and use a Kardia mobile during those recordings.
The HeartWatch data will not be used for clinical decision-making. Rhythm strips from conventional 12-lead ECG recordings and the HeartWatch recordings will be obtained in volunteers in supine and standing positions and with the device placed in the recommended and in non-recommended positions (i.e., internally and externally rotated in keeping with the observed malposition identified in human factors testing environments (one inch or 2.5 cm; HelpWear, data on file).
Rhythm strips from serial 10-sec, 12-lead recordings will be obtained to allow for beat-by-beat comparisons of ECG intervals over the 20 to 30 seconds of noise free data. Specifically, the intervals from continuous v4 beats with paired continuous HeartWatch beats and the intervals from continuous lead I beats with paired continuous Kardia beats.
Since the HeartWatch is not intended to be used for evaluation of the ST segment or the QT interval, the comparison of the HeartWatch to standard lead v4 will exclude QT assessment.
- Conditions
- ECG Monitoring
- Being tested
- ECG signals collection
- Keywords
- Heart Signals, ECG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG signals collectionDevice
Also called Standard 12 lead ECG, Kardia ECG, Heartwatch ECG
A Health-Canada and FDA-approved 12-lead ECG system (GE Healthcare, MAC 5500 or equivalent) will be used to collect the 10-sec digital rhythm strips in the noted supine and standing positions.
A total of twenty-four (24) recordings, four from each of position, will be collected from each consenting participant:
- Supine with HeartWatch in the recommended position
- Standing with HeartWatch in the recommended position
- Supine with HeartWatch in a one inch (2.5 cm) externally rotated position
- Supine with HeartWatch in a one inch (2.5 cm) internally rotated position
- Supine while collecting a 30-sec Kardia recording
- Standing while collecting a 30-sec Kardia recording
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Volunteers undergoing a conventional 12-lead ECG who agree to wear a HeartWatch and use a Kardia mobile device during that ECG recording. Receives: Device: ECG signals collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard ECG and HeartWatch interval duration assessment in standard position
The three co-primary efficacy endpoints for this study are beat-by-beat QRS intervals, PQ intervals, and P wave durations in continuous ECG (HeartWatch vs. lead v4 of a standard 12-lead ECG) in a supine position with the HeartWatch in the standard location.
Measured: The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection testing visit.
Secondary outcomes (1)
ECG interval assessment with the heart watch and the 12 Lead ECG in non traditional positions.
Secondary efficacy endpoints for this study are beat-by-beat QRS intervals, PQ intervals, and P wave durations in continuous ECG (HeartWatch vs. lead v4 of a standard 12-lead ECG) in a:
- standing position with the HeartWatch in the standard location;
- supine position with the HeartWatch in a one inch (2.5 cm) externally rotated;
- supine position with the HeartWatch in a one inch (2.5 cm) internally rotated.
Measured: The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection from their testing visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start18 Feb 2026
- Primary completion24 Mar 2026
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ECG MonitoringStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- HelpWear Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624435
- Sponsor's protocol ID
- CLONE Version 1.0
- Acronym
- CLONE
- Status last verified
- Sep 2026
- First submitted
- 27 May 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This information will be used to validate a company's Intellectual property
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Lead Opposed to Novel ECG
- ClinicalTrials.gov ID
- NCT07624435
- Acronym / sponsor ID
- CLONE / CLONE Version 1.0
- Conditions
- ECG Monitoring
- Keywords
- Heart Signals, ECG
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- HelpWear Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 3 Jun 2026 (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.
To blindly assess, beat-by-beat, standard ECG intervals (QRS intervals, PQ intervals, and P wave durations) of paired standard lead v4 with paired HeartWatch signals over 20 to 30 seconds of noise-free data.
Detailed description
This proof-of-concept study will enroll volunteers undergoing serial conventional 12-lead ECG rhythm strips who agree to wear a HeartWatch and use a Kardia mobile during those recordings.
The HeartWatch data will not be used for clinical decision-making. Rhythm strips from conventional 12-lead ECG recordings and the HeartWatch recordings will be obtained in volunteers in supine and standing positions and with the device placed in the recommended and in non-recommended positions (i.e., internally and externally rotated in keeping with the observed malposition identified in human factors testing environments (one inch or 2.5 cm; HelpWear, data on file).
Rhythm strips from serial 10-sec, 12-lead recordings will be obtained to allow for beat-by-beat comparisons of ECG intervals over the 20 to 30 seconds of noise free data. Specifically, the intervals from continuous v4 beats with paired continuous HeartWatch beats and the intervals from continuous lead I beats with paired continuous Kardia beats.
Since the HeartWatch is not intended to be used for evaluation of the ST segment or the QT interval, the comparison of the HeartWatch to standard lead v4 will exclude QT assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: ECG signals collectionVolunteers undergoing a conventional 12-lead ECG who agree to wear a HeartWatch and use a Kardia mobile device during that ECG recording. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers undergoing a conventional 12-lead ECG who agree to wear a HeartWatch and use a Kardia mobile device during that ECG recording.
Key inclusion criteria (3 listed)
- At least 22 years of age at time of the conventional ECG recording
- Willing to participate in the study
- Able to follow the protocol
Key exclusion criteria (7 listed)
- Known allergy to the electrodes used for a conventional ECG
- Known allergy to any component of the HeartWatch
- Known allergy to any component of the Kardia system
- Inability to wear the HeartWatch on the left arm due to pre-existing medical condition (e.g., functional AV fistula in left arm, prior carcinoma with lymph node dissection or lymphedema, known blood clot or recurrent blood clots in left arm, chronic neuropathic pain in left arm, …)
- Dextrocardia
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 |
|---|---|---|
| ECG signals collectionAlso: Standard 12 lead ECG, Kardia ECG, Heartwatch ECGA Health-Canada and FDA-approved 12-lead ECG system (GE Healthcare, MAC 5500 or equivalent) will be used to collect the 10-sec digital rhythm strips in the noted supine and standing positions. A total of twenty-four (24) recordings, four from each of position, will be collected from each consenting participant: * Supine with HeartWatch in the recommended position * Standing with HeartWatch in the recommended position * Supine with HeartWatch in a one inch (2.5 cm) externally rotated position * Supine with HeartWatch in a one inch (2.5 cm) internally rotated position * Supine while collecting a 30-sec Kardia recording * Standing while collecting a 30-sec Kardia recording | Device | Healthy volunteers |
Primary outcome
Standard ECG and HeartWatch interval duration assessment in standard position
Time frame: The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection testing visit.
The three co-primary efficacy endpoints for this study are beat-by-beat QRS intervals, PQ intervals, and P wave durations in continuous ECG (HeartWatch vs. lead v4 of a standard 12-lead ECG) in a supine position with the HeartWatch in the standard location.
1 secondary outcome
ECG interval assessment with the heart watch and the 12 Lead ECG in non traditional positions.
Time frame: The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection from their testing visit.
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 17 Sep 2026.
- Individual participant dataSharing planned: No. This information will be used to validate a company's Intellectual property
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ECG Monitoring, run by HelpWear 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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. 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?
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?
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?
Standard ECG and HeartWatch interval duration assessment in standard position (time frame: The data for this outcome will be collected for each participant in their testing visit. All data is then assessed within two weeks of the data collection testing visit.). 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 17 Sep 2026.