PacemakereCarIINCT05361681
EMI and CIED: Is High Power Charging of Battery Electric Car Safe?
A study testing Electromagnetic Field Exposure in people with Pacemaker and ICD, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Electromagnetic Field Exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- implanted cardiac implantable electronic device with regular function
Who cannot join
- implanted cardiac implantable electronic device with irregular function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Electromagnetic Field Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| interventional arm | Experimental | Participants were charging full electric cars, using high power charging systems Receives: Other: Electromagnetic Field Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromagnetic interference
Occurence of electromagnetic interference during an exposure time of up to 5 minutes
Measured: during the intervention, i.e. when participants are exposed to the electromagnetic field of the high power charging column
Secondary outcomes (1)
Electromagnetic fields
Measuring the electromagnetic fields while super-charging along the charging cable, the column and the car connector
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Jun 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Exposure of patients with pacemaker or ICD to the electromagnetic fields of high power charging systems
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361681
- Sponsor's protocol ID
- GER-EP-024
- Acronym
- eCarII
- Status last verified
- Aug 2021
- First submitted
- 31 Aug 2021
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Electromagnetic Interference Between Cardiac Implantable Electronic Devices and High Power Charging Systems for Battery Electric Cars
- ClinicalTrials.gov ID
- NCT05361681
- Acronym / sponsor ID
- eCarII / GER-EP-024
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Exposure of patients with pacemaker or ICD to the electromagnetic fields of high power charging systems
| Arm | Type | Receives |
|---|---|---|
| interventional arm | Experimental | Other: Electromagnetic Field ExposureParticipants were charging full electric cars, using high power charging systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- implanted cardiac implantable electronic device with regular function
Key exclusion criteria (1 listed)
- implanted cardiac implantable electronic device with irregular function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromagnetic Field ExposureAll participants were exposed to the electromagnetic field of 4-5 different high power charging systems, charging 4-5 different, commercially available full electric cars | Other | interventional arm |
Primary outcome
Electromagnetic interference
Time frame: 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
1 secondary outcome
Electromagnetic fields
Time frame: during the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromagnetic Field Exposure in people with Pacemaker and ICD, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromagnetic interference (time frame: during the intervention, i.e. when participants are exposed to the electromagnetic field of the high power charging column). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.