NCT06164808 Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch
| NCT ID | NCT06164808 |
| Status | Recruiting |
| Phase | — |
| Sponsor | HelpWear Inc. |
| Condition | Cardiac Arrhythmia |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2024-02-20 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility 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
Contact & Investigator
Russell Quinn, MD
PRINCIPAL INVESTIGATOR
University of Calgary
Frequently Asked Questions
Who can join the NCT06164808 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Cardiac Arrhythmia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06164808 currently recruiting?
Yes, NCT06164808 is actively recruiting participants. Contact the research team at kcowan@ucalgary.ca for enrollment information.
Where is the NCT06164808 trial being conducted?
This trial is being conducted at Calgary, Canada.
Who is sponsoring the NCT06164808 clinical trial?
NCT06164808 is sponsored by HelpWear Inc.. The principal investigator is Russell Quinn, MD at University of Calgary. The trial plans to enroll 300 participants.