Hexoskin Medical System - ECG Performance Testing

HMS ECG Clinical Validation Study - Protocol External Site

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Rhythm Disturbance
• Intervention / Treatment: Device: Hexoskin Medical System

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 high correlations 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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Yutian Shu, Ph.D.; Phone Number: 888-887-2044; Email: yutian.shu@carretechnologies.com

Study Locations

• Canada
  • North York, Canada
    • Recruiting
    • Yorkview Cardiology
    • Contact: Aynur Tremblay; Phone Number: 416-882-1878; Email: aynur@ycardiology.com
    • Principal Investigator: Christopher Cheung, MD
    • Sub-Investigator: Eugene Crystal, MD
  • Ontario
    • Toronto, Ontario, Canada, M4N 3N1
      • Recruiting
      • Lawrence Park Cardiology
      • Contact: Aynur Tremblay; Phone Number: 416-882-1878; Email: aynur@ycardiology.com
      • Principal Investigator: Christopher Cheung, MD
      • Sub-Investigator: Eugene Crystal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients consulting the cardiology clinics

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Participant wears both the Hexoskin Medical System and the Nasiff Holter Monitor at the same time to acquire ECG recordings.; Other Names: Nasiff Holter Monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac beat detection agreement	The level of agreement between using the HMS and the Holter monitor (reference standard) ECG recordings in detection of beats	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECG characteristics measurement agreement	The agreement (as evidenced by establishment of a positive linear relationship) of Holter monitor(reference standard) and HMS to measure each of the eight (8) ECG Characteristics. ECG characteristics measured in this study include: RR Interval (ms), PR Interval (ms), PP Interval (ms), QRS Duration (ms), QRS Amplitude (mV), P Wave Duration (ms), P Wave Amplitude (mV), and QT Interval (ms).	2 days
Cardiac rhythm outcome agreement	The agreement of using Holter monitor (reference standard) and HMS ECG recordings to detect cardiac rhythms or rhythm disturbances.	2 days
Cardiac beat detection accuracy	The Sensitivity and Positive Predictive Value (PPV) of using the HMS ECG recordings to detect cardiac beats.	2 days
Cardiac rhythm identification accuracy	The Sensitivity and PPV of using the HMS ECG recordings to identify cardiac rhythm/rhythm disturbance.	2 days

Collaborators and Investigators

• Sponsor: Carré Technologies Inc.
• Investigators: Principal Investigator: Christopher Cheung, MD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Estimated): April 24, 2024
• Study Completion (Estimated): April 24, 2024

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Hexoskin Medical System (HMS); Cardiac Rhythm Disturbance
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: HMS_ECG_external; 361070 (Other Identifier: Health Canada Investigation Testing Authorization)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No