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Completed

NCT Number: NCT03826225

Cardiac Monitor Employee Study

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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Key information

Conditions

Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Scientific

Saint Paul, Minnesota, 55112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluate WCM System End-To-End Performance

    Time frame: 3 months

    Characterize rate of success of wireless data transmissions from wearable cardiac monitor to LATITUDE Clarity(TM) server

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: CARMEL

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 1, 2019
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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