Clinical trial NCT05970328: Hexoskin Medical System - ECG Performance Testing
Official title: HMS ECG Clinical Validation Study - Protocol External Site
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Rhythm Disturbance
Keywords: Hexoskin Medical System (HMS)
Cardiac Rhythm Disturbance
Lead sponsor: Carré Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients consulting the cardiology clinics

Brief summary: The goal of this observational study is to validate the efficacy of the Hexoskin Medical System (HMS) for its intended use (i.e., manual assessment of cardiac rhythm disturbances) in non-critical adult participants who are suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor.

Detailed description: The main questions it aims to answer are:

1. Whether the HMS ECG recordings can be used to accurately detect cardiac beats when compared with the Holter monitor
2. Whether there are good agreements between the HMS and Holter monitor in ECG characteristics
3. Whether the HMS ECG recordings can be used to accurately classify cardiac rhythm/rhythm disturbance when compared with the Holter monitor
4. What is the accuracy of using HMS ECG recordings to detect cardiac beats
5. What is the accuracy of using HMS ECG recordings to identify cardiac rhythm/rhythm disturbance

Participants will wear the HMS and the Holter monitor at the same time to record ECG signals. Researchers will evaluate the ECG recordings acquired from both devices and assess the above questions.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Male or female, aged 21 years or older.
* Participants must be suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor.

Exclusion Criteria:

* Body circumference that is not covered by the HMS Shirt sizing chart
* Presence of pacemaker or Implantable Cardioverter-Defibrillator (ICD) devices
* Known allergic reactions to silver or polyamide/polyester/elastane
* Known allergic reactions to ECG gel electrodes
* Documented medical condition or illness requiring intensive medical treatment or care

Primary outcomes:
measure: ECG characteristics measurement agreement
timeFrame: 2 days
Secondary outcomes:
measure: Heart rate agreement
timeFrame: 2 days
Other outcomes:
measure: Cardiac beat detection accuracy
timeFrame: 2 days
measure: Rhythm identification accuracy
timeFrame: 2 days
measure: ECG recording stability
timeFrame: 2 days
Locations:
city: Toronto
country: Canada
facility: Lawrence Park Cardiology
state: Ontario
city: North York
country: Canada
facility: Yorkview Cardiology
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Christopher Cheung, MD
role: PRINCIPAL_INVESTIGATOR
References: