HeartWatch vs Holter: A Longer-Term Arm Monitors Heart Rhythm
Official title: Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch
Run by HelpWear Inc. · NCT06164808 · Data updated 2026-11-12
This study tests whether the HeartWatch arm monitor can match or improve on Holter monitoring for detecting rhythm problems in adults with suspected AF and other arrhythmias.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | HelpWear Inc. Industry-sponsored |
| Locations | 1 site (Calgary, Alberta) |
| Status | Recruiting |
| Started | February 20, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT06164808 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (22 years and older) who are clinically indicated for Holter monitoring and can wear HeartWatch on the left bicep for the study duration.
✕Probably not a fit
Patients with left-arm contraindications or those unable to wear HeartWatch for the full study period may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults referred for Holter monitoring will wear both a HeartWatch on the left arm and a Holter monitor to compare signal accuracy and autodetect algorithms between the two devices. The study also looks at how often adverse events are captured by each system and assesses which device patients prefer. Data will be collected on heart rhythm events, symptom correlations, and device performance over the monitoring period. The HeartWatch provides app-based tagging and longer-term wear, aiming to improve detection without invasive implants. Results will inform whether HeartWatch offers comparable or superior monitoring for arrhythmias.
Why it matters
Potential benefit: If successful, HeartWatch could provide continuous, noninvasive rhythm monitoring with reliable automatic detection and better patient experience.
How similar studies have gone: Previous efforts in wearable cardiac monitoring show promise, but this direct head-to-head in a clinical setting is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
Foothills Medical Centre University of Calgary
Calgary, Alberta, Canada Recruiting
Study contacts
- Principal investigator: Russell Quinn, MD — University of Calgary
- Study coordinator: Karen Cowan
- Email: kcowan@ucalgary.ca
- Phone: 4035600225
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.