Assessment of Electromagnetic Interference Between E-tran... | NCT02252575

Studies
Assessment of Electromagnetic Interference Between E-transportation and Cardiac Implantable Electronic Devices

NCT02252575

Sponsor

Deutsches Herzzentrum Muenchen

Status

Completed

Last Update Posted

Feb 5, 2018Actual

Enrollment

107Actual

Phase

Not Applicable

Conditions

Electromagnetic Interference

Interventions

Electromagnetic field

Countries

Germany

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

Feb 2018

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

Sep 2014Actual

Primary Completion Date

Apr 2015Actual

Completion Date

Oct 2017Actual

First Submitted Date

Sep 26, 2014

First Submission Date that Met QC Criteria

Sep 26, 2014

First Posted Date

Sep 30, 2014Estimated

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

Feb 1, 2018

Last Update Posted Date

Feb 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

E-Transportation is increasing all over the world. It is not known if the used engines interfere with cardiac implantable electronic devices. The study evaluates such potential interferences in vivo.

Detailed Description

E-Transportation is increasing all over the world. It is not known if the used engines interfere with cardiac implantable electronic devices. The study evaluates different types of electric motors with regard to electromagnetic interference with implanted pacemakers or cardioverter-defibrillators.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

107Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Electromagnetic field	Experimental	Exposure to the elctromagnetic field of an electric motor	Device: Electromagnetic field

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Electromagnetic field	Device	Exposure to the electromagnetic fields of electric motors	Electromagnetic field

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of electromagnetic interference	Occurrence of electromgantic interference during an exposure time of approximately 5 minutes	acute setting

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

implanted cardiac implantable electronic device with regular function

Exclusion Criteria:

implanted cardiac implantable electronic device with irregular function

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christof Kolb, MD	Deutsches Herzzentrum München	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Deutsches Herzzentrum Muenchen		Munich		80636	Germany