Hexoskin Medical System - ECG Performance Testing

NCT05970328 | Completed

• 2 other identifiers: HMSECG23361070
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiac Rhythm Disturbance

Keywords

Hexoskin Medical System (HMS); Cardiac Rhythm Disturbance

Outcome Measures

Primary Outcomes (1)

• ECG characteristics measurement agreement

  The agreement (Bland-Altman plots) of Holter monitor(reference standard) and HMS to measure each of the four (4) ECG Characteristics. ECG characteristics measured in this study include: RR Interval (ms), PR Interval (ms), PP Interval (ms), and QRS Duration (ms).

  2 days

Secondary Outcomes (1)

• Heart rate agreement

  2 days

Other Outcomes (3)

• Cardiac beat detection accuracy

  2 days

• Rhythm identification accuracy

  2 days

• ECG recording stability

  2 days

Study Arms (1)

Arrhythmia Participant

Non-critical adult (21 years and older) participants that are suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor.

Device: Hexoskin Medical System

Interventions

Hexoskin Medical System DEVICE

Participant wears both the Hexoskin Medical System and the Nasiff Holter Monitor at the same time to acquire ECG recordings.

Also known as: Nasiff Holter Monitor

Arrhythmia Participant

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients consulting the cardiology clinics

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Carré Technologies Inc.: lead

Study Sites (2)

Lawrence Park Cardiology

Toronto, Ontario, M4N 3N1, Canada

Location

Yorkview Cardiology

North York, Canada

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Cheung, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: July 24, 2023
• Primary Completion: February 17, 2024
• Study Completion: February 17, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)