An observational study in Cardiac Rhythm Disturbance, sponsored by Carré Technologies Inc.. Completed at 2 sites in Canada. Open to participants aged 21 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Carré Technologies Inc. · Observational
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.
915 studies on the registry are indexed under Arrhythmias, Cardiac; 234 are open to participants now.
This study's enrollment of 75 is below the median of 200 across 426 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →This is the only study on the registry with Carré Technologies Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Consecutive patients consulting the cardiology clinics
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Also known as: Nasiff Holter Monitor
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).
Time frame: 2 days
Heart rate agreement
The agreement between HR calculated from the recordings acquired by the subject device and the reference Holter monitor.
Time frame: 2 days
Cardiac beat detection accuracy
The sensitivity and PPV of using the subject device recordings to detect cardiac beats.
Time frame: 2 days
Rhythm identification accuracy
The sensitivity and PPV of using the subject recordings to identify cardiac rhythm/rhythm disturbances.
Time frame: 2 days
ECG recording stability
The stability of the subject device for recording ECG through 24 hours of ambulatory ECG monitoring.
Time frame: 2 days
Plan to share: No — There is no plan to make IPD available.
No publications or documents are linked to this record.
Ran from Jul 2023 to primary completion in Feb 2024, 6 months.
Of 62 industry-sponsored observational studies under Arrhythmias, Cardiac, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 53. This study's 6 months is below that.
Counting every sponsor, half of 243 studies reached it within 37 months; a quarter within 15 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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