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

• Sponsor: Deutsches Herzzentrum Muenchen (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05361681
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pacemaker; ICD	Other: Electromagnetic Field Exposure	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Exposure of patients with pacemaker or ICD to the electromagnetic fields of high power charging systemsExposure of patients with pacemaker or ICD to the electromagnetic fields of high power charging systems
• Masking: None (Open Label)
• Masking Description: Assessor is blinded regarding patient and details of intervention (i.e. which charging column and which electric cars were used)
• Primary Purpose: Other
• Official Title: Assessment of Electromagnetic Interference Between Cardiac Implantable Electronic Devices and High Power Charging Systems for Battery Electric Cars
• Actual Study Start Date: Jun 1, 2021
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Electromagnetic interference [during the intervention, i.e. when participants are exposed to the electromagnetic field of the high power charging column]

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

Secondary Outcome Measures

1. Electromagnetic fields [during the intervention]

   Measuring the electromagnetic fields while super-charging along the charging cable, the column and the car connector

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• implanted cardiac implantable electronic device with regular function

Exclusion Criteria:

• implanted cardiac implantable electronic device with irregular function

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Deutsches Herzzentrum München	Munich	Bayern	Germany	80636

Sponsors and Collaborators

• Deutsches Herzzentrum Muenchen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deutsches Herzzentrum Muenchen
• ClinicalTrials.gov Identifier: NCT05361681
• Other Study ID Numbers: GER-EP-024
• First Posted: May 5, 2022
• Last Update Posted: May 5, 2022
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 5, 2022