Cardiac Monitor Employee Study (CARMEL)

Boston Scientific

Status: Completed

Conditions: Arrhythmias, Cardiac

Study type: Observational

Funder types: Industry

Identifiers

NCT03826225

CARMEL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Study Cohort

Description:

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.