Clinical trial NCT06164808: Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch
Official title: Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Arrhythmia
Diagnostic/Monitoring Devices Related to Adverse Incidents
Lead sponsor: HelpWear Inc.
Sponsor class: INDUSTRY
First posted: 2023-12-11
Enrollment: 205
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will wear the Holter monitor and the HeartWatch.
Primary purpose: DIAGNOSTIC

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.

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.

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

Primary outcomes:
measure: QRS signal detection
timeFrame: For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours
Secondary outcomes:
measure: ECG strip evaluation
timeFrame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
measure: ECG PR interval assessment
timeFrame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
measure: ECG QRS interval assessment
timeFrame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
measure: ECG interval assessment
timeFrame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
Other outcomes:
measure: Adverse events
timeFrame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
measure: User preference
timeFrame: For the duration of time that the subject wears the holter vs the HeartWatch (24-48 hours).
measure: ECG strip categorization
timeFrame: For the duration of time that the patient wears the Holter monitor and the HeartWatch, 24-48 hours.
measure: Future software validation
timeFrame: Data obtained during the recordings will be used for future software validation for 5 years.
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Russell Quinn, MD
role: PRINCIPAL_INVESTIGATOR
References: