Hexoskin Medical System - ECG Performance Testing

Study Overview
=================
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 that are suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor. The main question it aims to answer are: Whether the HMS ECG recordings can be used to accurately detect cardiac beats when compared with the Holter monitor Whether there are high correlations between the HMS and Holter monitor in ECG characteristics Whether the HMS ECG recordings can be used to accurately classify cardiac rhythm/rhythm disturbance when compared with the Holter monitor What is the accuracy of using HMS ECG recordings to detect cardiac beats 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.

Official Title
-----------------
HMS ECG Clinical Validation Study - Protocol External Site

Conditions
-----------------
Cardiac Rhythm Disturbance

Intervention / Treatment
-----------------
* Device: Hexoskin Medical System


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arrhythmia Participant<br>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<br>* Participant wears both the Hexoskin Medical System and the Nasiff Holter Monitor at the same time to acquire ECG recordings.<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hexoskin Medical System (HMS), Cardiac Rhythm Disturbance