Cardiac Rhythm Disturbance
Conditions
Keywords
Hexoskin Medical System (HMS), Cardiac Rhythm Disturbance
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.
Interventions
DEVICEHexoskin Medical System
Participant wears both the Hexoskin Medical System and the Nasiff Holter Monitor at the same time to acquire ECG recordings.
Sponsors
Carré Technologies Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ECG characteristics measurement agreement | 2 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate agreement | 2 days | The agreement between HR calculated from the recordings acquired by the subject device and the reference Holter monitor. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardiac beat detection accuracy | 2 days | The sensitivity and PPV of using the subject device recordings to detect cardiac beats. |
| Rhythm identification accuracy | 2 days | The sensitivity and PPV of using the subject recordings to identify cardiac rhythm/rhythm disturbances. |
| ECG recording stability | 2 days | The stability of the subject device for recording ECG through 24 hours of ambulatory ECG monitoring. |
Countries
Canada
Outcome results
None listed