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NCT03826225 Clinical Trial

Cardiac Monitor Employee Study

Arrhythmias, Cardiac Clinical Trial

— CARMEL  

Official title:
Cardiac Monitor Employee Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03826225
Other study ID # CARMEL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 7, 2019
Est. completion date May 23, 2019

Study information
Verified date July 2019
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date May 23, 2019
Est. primary completion date May 23, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Boston Scientific Saint Paul Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

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