Cardiac ArrhythmiaCATCHNCT06164808
Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch
A study testing HeartWatch in people with Cardiac Arrhythmia and Diagnostic/Monitoring Devices Related to Adverse Incidents, run by HelpWear Inc. at 1 site in Canada.
Trial summary
Heart rhythm disorders are common and significantly impact the lives of those affected and their families. The main problems can be categorized as: a) atrial fibrillation or AF and atrial flutter, b) supra-ventricular tachycardia or SVT, c) excessively slow heart beats (i.e., bradycardia or pauses) and d) ventricular… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cardiac Arrhythmia, Diagnostic/Monitoring Devices Related to Adverse Incidents, Atrial Fibrillation (AF)
- What is being tested?
- HeartWatch
- 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
- 20 Feb 2024to 31 Dec 2026
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 22 years of age at time of consent
- Clinically indicated for a Holter monitor test
- Able to wear the HeartWatch on the left bicep for the study duration
- Able to follow the protocol
- No functional implantable pacemaker or defibrillator
- Left bicep circumference >/= 22 cm and </= 45 cm
- Provision of written-informed consent
Who cannot join
- Known allergy to any component of the Holter monitor
- Known allergy to any component of the HeartWatch
- Inability to wear the HeartWatch on the left arm for the study period due to pre-existing medical condition (3.g., functional AV fistula in left arm, prior carcinoma with lymph node dissection or lymphedema, known blood clot of recurrent blood clots in the left arm, chronic neuropathic pain in left arm, ...)
- Dextrocardia
- Implanted functional Pacemaker or Defibrillator
- Left bicep circumference < 22 cm
- Left bicep circumference < 45 cm
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
Foothills Medical Centre University of Calgary
Calgary, Alberta, T2N 4N1
Russell Quinn, MD, 403-220-5500, frquinn@ucalgary.ca
About this study
Heart rhythm disorders are common and significantly impact the lives of those affected and their families. The main problems can be categorized as: a) atrial fibrillation or AF and atrial flutter, b) supra-ventricular tachycardia or SVT, c) excessively slow heart beats (i.e., bradycardia or pauses) and d) ventricular arrhythmias. These problems can be difficult to detect with currently available monitoring options as they are all worn for shorter terms or are an invasive implantable option. The HeartWatch is a longer term monitoring system that is worn on the upper arm, allows users to create a tag and pairs with an app on a smartphone allowing for correlation of symptoms.
Read the detailed description
Patients who are being referred to wear a holter monitor will be approached to wear a HeartWatch simultaneously. This will allow collection of signals on both devices and to compare the accuracy of signals between the Heartwatch vs Holter monitor. It will also examine the reliability of autodetect algorythms between the devices. We will also collect information to compare the amount of adverse events between the various systems and the patient preference of those systems.
- Conditions
- Cardiac Arrhythmia, Diagnostic/Monitoring Devices Related to Adverse Incidents, Atrial Fibrillation (AF)
- Being tested
- HeartWatch
- Medical subject headings
- Arrhythmias, Cardiac, Disease, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartWatchDevice
The HeartWatch is indicated for the extended diagnostic evaluation of patients with symptomatic and transient symptoms such as light-headedness, syncope, and palpitations, as well as patients at risk for arrhythmias, but without significant symptoms. It is an armband consisting of the main body of the device with an additional sensor located on the band. It is worn around the upper left arm to obtain heart electrical signals. The device is paired with the HelpWear application on a smartphone where the signals are stored and then will be uploaded to a secure network for analysis.
| Study group | Role | What they receive |
|---|---|---|
| Active device engagement | Other | All subjects will wear either the Holter monitor and the HeartWatch. Receives: Device: HeartWatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
QRS signal detection
Compare QRS detection accuracy with HeartWatch data vs. the Holter monitor lead I signal
Measured: For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours
Secondary outcomes (4)
ECG strip evaluation
Compare the overall agreement of the HeartWatch vs. Holter data in providing interpretable ECG strips data for all symptomatic (patient tagged) events and all cardiologist-verified non-normal rhythms identified by cardiology technologists (Holter).
Measured: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
ECG PR interval assessment
Assess the comparability of paired, 10-minute averaged PR intervals measured from the HeartWatch vs. the Holter lead I reference signal.
Measured: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
ECG QRS interval assessment
Assess the comparability of paired, 10-minute averaged QRS intervals measured from the HeartWatch vs. the Holter lead I reference signal.
Measured: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
ECG interval assessment
Assess the comparability of paired, 10-minute averaged heart rate corrected QT (QTc) intervals measured from the HeartWatch vs. the Holter lead I reference signal.
Measured: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start20 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Model description
- All subjects will wear the Holter monitor and the HeartWatch.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HelpWear Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russell Quinn, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164808
- Sponsor's protocol ID
- CATCH V3.1
- Acronym
- CATCH
- Status last verified
- Jun 2026
- First submitted
- 1 Dec 2023
- Last updated
- 9 Jun 2026
- Results posted
- 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 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch
- ClinicalTrials.gov ID
- NCT06164808
- Acronym / sponsor ID
- CATCH / CATCH V3.1
- Conditions
- Cardiac Arrhythmia, Diagnostic/Monitoring Devices Related to Adverse Incidents, Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- HelpWear Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Dec 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.
Heart rhythm disorders are common and significantly impact the lives of those affected and their families. The main problems can be categorized as: a) atrial fibrillation or AF and atrial flutter, b) supra-ventricular tachycardia or SVT, c) excessively slow heart beats (i.e., bradycardia or pauses) and d) ventricular arrhythmias. These problems can be difficult to detect with currently available monitoring options as they are all worn for shorter terms or are an invasive implantable option. The HeartWatch is a longer term monitoring system that is worn on the upper arm, allows users to create a tag and pairs with an app on a smartphone allowing for correlation of symptoms.
Detailed description
Patients who are being referred to wear a holter monitor will be approached to wear a HeartWatch simultaneously. This will allow collection of signals on both devices and to compare the accuracy of signals between the Heartwatch vs Holter monitor. It will also examine the reliability of autodetect algorythms between the devices. We will also collect information to compare the amount of adverse events between the various systems and the patient preference of those systems.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will wear the Holter monitor and the HeartWatch.
| Arm | Type | Receives |
|---|---|---|
| Active device engagement | Other | Device: HeartWatchAll subjects will wear either the Holter monitor and the HeartWatch. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 22 years of age at time of consent
- Clinically indicated for a Holter monitor test
- Able to wear the HeartWatch on the left bicep for the study duration
- Able to follow the protocol
- No functional implantable pacemaker or defibrillator
Key exclusion criteria (7 listed)
- Known allergy to any component of the Holter monitor
- Known allergy to any component of the HeartWatch
- Inability to wear the HeartWatch on the left arm for the study period due to pre-existing medical condition (3.g., functional AV fistula in left arm, prior carcinoma with lymph node dissection or lymphedema, known blood clot of recurrent blood clots in the left arm, chronic neuropathic pain in left arm, ...)
- Dextrocardia
- Implanted functional Pacemaker or Defibrillator
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 |
|---|---|---|
| HeartWatchThe HeartWatch is indicated for the extended diagnostic evaluation of patients with symptomatic and transient symptoms such as light-headedness, syncope, and palpitations, as well as patients at risk for arrhythmias, but without significant symptoms. It is an armband consisting of the main body of the device with an additional sensor located on the band. It is worn around the upper left arm to obtain heart electrical signals. The device is paired with the HelpWear application on a smartphone where the signals are stored and then will be uploaded to a secure network for analysis. | Device | Active device engagement |
Primary outcome
QRS signal detection
Time frame: For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours
Compare QRS detection accuracy with HeartWatch data vs. the Holter monitor lead I signal
4 secondary outcomes
ECG strip evaluation
Time frame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
ECG PR interval assessment
Time frame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
ECG QRS interval assessment
Time frame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
ECG interval assessment
Time frame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
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 9 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrhythmia
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VOLT CE Mark Study
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EDEN Intracardiac Electrogram Recording and Classifying System
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RecruitingObservational study
Southeast Asian Brugada Syndrome Cohort
Brugada Syndrome
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VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
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Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
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.
Russell Quinn, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartWatch in people with Cardiac Arrhythmia and Diagnostic/Monitoring Devices Related to Adverse Incidents, run by HelpWear Inc. 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 7 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: looking for participants now, as of the sponsor's last update on 9 Jun 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?
Contact Karen Cowan (4035600225, kcowan@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QRS signal detection (time frame: For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours). 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 9 Jun 2026.