Electromagnetic InterferenceNCT02252575
Assessment of Electromagnetic Interference Between E-transportation and Cardiac Implantable Electronic Devices
A study testing Electromagnetic field in people with Electromagnetic Interference, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electromagnetic Interference
- What is being tested?
- Electromagnetic field
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Oct 2017
- 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
- No healthy volunteers
- 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
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.
Read the detailed description
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 different types of electric motors with regard to electromagnetic interference with implanted pacemakers or cardioverter-defibrillators.
- Conditions
- Electromagnetic Interference
- Being tested
- Electromagnetic field
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic fieldDevice
Exposure to the electromagnetic fields of electric motors
| Study group | Role | What they receive |
|---|---|---|
| Electromagnetic field | Experimental | Exposure to the elctromagnetic field of an electric motor Receives: Device: Electromagnetic field |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of electromagnetic interference
Occurrence of electromgantic interference during an exposure time of approximately 5 minutes
Measured: acute setting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2015
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electromagnetic InterferenceStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christof Kolb, MD, Study chair, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252575
- Sponsor's protocol ID
- GER-EP-014
- Status last verified
- Feb 2018
- First submitted
- 26 Sep 2014
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Electromagnetic Interference Between E-transportation and Cardiac Implantable Electronic Devices
- ClinicalTrials.gov ID
- NCT02252575
- Acronym / sponsor ID
- GER-EP-014
- Conditions
- Electromagnetic Interference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 30 Sep 2014 (estimated)
- 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.
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.
Detailed description
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 different types of electric motors with regard to electromagnetic interference with implanted pacemakers or cardioverter-defibrillators.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electromagnetic field | Experimental | Device: Electromagnetic fieldExposure to the elctromagnetic field of an electric motor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not 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 fieldExposure to the electromagnetic fields of electric motors | Device | Electromagnetic field |
Primary outcome
Occurrence of electromagnetic interference
Time frame: acute setting
Occurrence of electromgantic interference during an exposure time of approximately 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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.
Christof Kolb, MD study chair
Deutsches Herzzentrum München
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 in people with Electromagnetic Interference, 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: finished, as of the sponsor's last update on 5 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of electromagnetic interference (time frame: acute setting). 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 Feb 2018.