NCT02252575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

7 months

First QC Date

September 26, 2014

Last Update Submit

February 1, 2018

Conditions

Electromagnetic Interference

Outcome Measures

Primary Outcomes (1)

  • Occurrence of electromagnetic interference

    Occurrence of electromgantic interference during an exposure time of approximately 5 minutes

    acute setting

Study Arms (1)

Electromagnetic field

EXPERIMENTAL

Exposure to the elctromagnetic field of an electric motor

Device: Electromagnetic field

Interventions

Electromagnetic fieldDEVICE

Exposure to the electromagnetic fields of electric motors

Electromagnetic field

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • implanted cardiac implantable electronic device with regular function

You may not qualify if:

  • implanted cardiac implantable electronic device with irregular function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

MeSH Terms

Interventions

Magnetic Field Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Christof Kolb, MD

    Deutsches Herzzentrum München

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2014

First Posted

September 30, 2014

Study Start

September 1, 2014

Primary Completion

April 1, 2015

Study Completion

October 1, 2017

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

DE(1)