Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch
Recruiting · NCT06164808 · Interventional (participants receive a specific treatment) · Lead sponsor: HelpWear Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed.
- Foothills Medical Centre University of Calgary - Calgary, Alberta, Canada