EMI and CIED: Is High Power Charging of Battery Electric Car Safe? (eCarII)

Assessment of Electromagnetic Interference Between Cardiac Implantable Electronic Devices and High Power Charging Systems for Battery Electric Cars

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pacemaker; ICD
• Intervention / Treatment: Other: Electromagnetic Field Exposure

Detailed Description

The use of electric cars for public and private transport is increasing all over the world. Moreover the charging technique is improving and enables very fast charging with the use of high power. It is not known if the use of high volume charging systems interfere with cardiac implantable electronic devices. The study evaluates different types of high volume charging systems connected to different full electric vehicles with regard to electromagnetic interference with implanted pacemakers or cardioverter-defibrillators.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bayern
    • Munich, Bayern, Germany, 80636
      • Deutsches Herzzentrum München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• implanted cardiac implantable electronic device with regular function

Exclusion Criteria:

• implanted cardiac implantable electronic device with irregular function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interventional arm; Participants were charging full electric cars, using high power charging systems	Other: Electromagnetic Field Exposure; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromagnetic fields	Measuring the electromagnetic fields while super-charging along the charging cable, the column and the car connector	during the intervention

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: GER-EP-024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No