Cardiac Monitor Employee Study

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

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-07

Study Completion Date

2019-05-23

Brief Summary

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This purpose of this study is to collect ECG data from a wearable cardiac monitor in order to evaluate end-to-end performance of a cardiac monitor system and associated data management accessories.

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Detailed Description

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The objective of this study is to evaluate the usability of the Wearable Cardiac Monitor (WCM) system including the WCM, Mobile Monitors (patient and clinician), Magnet and LATITUDE Clarity(TM) Server. The study will exercise the end-to-end system utilizing human ECG data generated by the wearable cardiac monitor.

Conditions

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Arrhythmias, Cardiac

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Cohort

All participants are considered to be in the study cohort and will have the study device placed externally on their skin in order to collect human ECG data.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Willing and capable to provide informed consent
* Age 18 or above
* Employee of the study sponsor
* Willing and able to follow protocol requirements

Exclusion Criteria

* Currently enrolled in another clinical study that interferes with data collection
* Currently implanted with an active medical electronic device
* Known allergies to the materials that may come in contact with the skin
* Any active skin condition on the chest reported by the subject

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes