Cardiac Monitor Employee Study | NCT03826225

Studies
Cardiac Monitor Employee Study

NCT03826225

Sponsor

Boston Scientific Corporation

Status

Completed

Last Update Posted

Jul 8, 2019Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Arrhythmias, Cardiac

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 7, 2019Actual

Primary Completion Date

May 23, 2019Actual

Completion Date

May 23, 2019Actual

First Submitted Date

Jan 24, 2019

First Submission Date that Met QC Criteria

Jan 30, 2019

First Posted Date

Feb 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2019

Last Update Posted Date

Jul 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Cohort		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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This study will enroll volunteer adult participants who are employees of the study sponsor and who meet all eligibility criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dave Perschbacher	Senior R&D Fellow	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston Scientific		Saint Paul	Minnesota	55112	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided