Cardiac Monitor Employee Study
Completed
- Conditions
- Arrhythmias, Cardiac
- Registration Number
- NCT03826225
- Lead Sponsor
- Boston Scientific Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Boston Scientific
🇺🇸Saint Paul, Minnesota, United States