NCT05361681

Brief Summary

It is not known if the use of high power charging systems for electric vehicles may interfere with the functionality of implanted pacemakers and cardioverter-defibrillators.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

May 5, 2022

Status Verified

August 1, 2021

Enrollment Period

1.1 years

First QC Date

August 31, 2021

Last Update Submit

May 2, 2022

Conditions

PacemakerICD

Outcome Measures

Primary Outcomes (1)

  • Electromagnetic interference

    Occurence of electromagnetic interference during an exposure time of up to 5 minutes

    during the intervention, i.e. when participants are exposed to the electromagnetic field of the high power charging column

Secondary Outcomes (1)

  • Electromagnetic fields

    during the intervention

Study Arms (1)

interventional arm

EXPERIMENTAL

Participants were charging full electric cars, using high power charging systems

Other: Electromagnetic Field Exposure

Interventions

Electromagnetic Field ExposureOTHER

All participants were exposed to the electromagnetic field of 4-5 different high power charging systems, charging 4-5 different, commercially available full electric cars

interventional arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
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 München

Munich, Bavaria, 80636, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Assessor is blinded regarding patient and details of intervention (i.e. which charging column and which electric cars were used)
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Exposure of patients with pacemaker or ICD to the electromagnetic fields of high power charging systems
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2021

First Posted

May 5, 2022

Study Start

June 1, 2021

Primary Completion

July 1, 2022

Study Completion

September 1, 2022

Last Updated

May 5, 2022

Record last verified: 2021-08

Locations

DE(1)