Hexoskin Medical System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-24

Study Completion Date

2024-02-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Rhythm Disturbance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Intervention Type DEVICE

Participant wears both the Hexoskin Medical System and the Nasiff Holter Monitor at the same time to acquire ECG recordings.

Interventions

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Hexoskin Medical System

Participant wears both the Hexoskin Medical System and the Nasiff Holter Monitor at the same time to acquire ECG recordings.

Intervention Type DEVICE

Other Intervention Names

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Nasiff Holter Monitor

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No