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| ID | Type | Description | Link |
|---|---|---|---|
| 361070 | Other Identifier | Health Canada Investigation Testing Authorization |
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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.
The main questions it aims to answer are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hexoskin Medical System | Device | Participant wears both the Hexoskin Medical System and the Nasiff Holter Monitor at the same time to acquire ECG recordings. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate agreement | The agreement between HR calculated from the recordings acquired by the subject device and the reference Holter monitor. | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac beat detection accuracy | The sensitivity and PPV of using the subject device recordings to detect cardiac beats. | 2 days |
| Rhythm identification accuracy | The sensitivity and PPV of using the subject recordings to identify cardiac rhythm/rhythm disturbances. |
Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients consulting the cardiology clinics
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Cheung, MD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lawrence Park Cardiology | Toronto | Ontario | M4N 3N1 | Canada | ||
| Yorkview Cardiology |
There is no plan to make IPD available.
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 2 days |
| ECG recording stability | The stability of the subject device for recording ECG through 24 hours of ambulatory ECG monitoring. | 2 days |
| North York |
| Canada |