Cardiac Monitor Employee Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03826225

Acronym

CARMEL

Enrollment

Registered

2019-02-01

Start date

2019-03-07

Completion date

2019-05-23

Last updated

2019-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias, Cardiac

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluate WCM System End-To-End Performance	3 months	Characterize rate of success of wireless data transmissions from wearable cardiac monitor to LATITUDE Clarity(TM) server

Countries

United States

Outcome results