Disorder of Cardiac Pacemaker SystemFEMUNCT01626261
Examination of Implant´s Safety in an Electronic and Magnetic Field Environment
An observational study of Disorder of Cardiac Pacemaker System and Disorder of Implantable Defibrillator, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The number of active electrical cardiac implants such as internal cardioverter defibrillators (ICDs), pacemakers or cardiac contractility modules (CCM) has significantly risen over the last two decades. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disorder of Cardiac Pacemaker System, Disorder of Implantable Defibrillator, Cardiac Arrhythmia
- What is being tested?
- Magnetic and electric field´s impact on the implant
- Type of treatment
- Medical device
- How many people
- 281 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Jun 2018
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: age between 18 and 80
Who may be able to join
- men and women between 18 and 80 years
- Implantation of a Pacemaker (SM)-/ ICD-assembly at least four weeks ago
- signed informed consent
Who cannot join
- enduring addiction of implant
- thyroid disease
- electrolyte imbalance on the trial day
- pregnancy and breastfeeding
- acute myocardial infarction (<30 days)
- Comorbidity, which complicates an emergency assistance, e.g. morbus bechterew, glaucoma, micturition disturbance
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universtiy Hospital RWTH Aachen
Aachen, Northrhine-Westfalia, 52074
About this study
Official title: Study of Provocation Concerning Implants´Safety in Electronic and Magnetic Fields in Their Environment
The number of active electrical cardiac implants such as internal cardioverter defibrillators (ICDs), pacemakers or cardiac contractility modules (CCM) has significantly risen over the last two decades. This has been paralleled by an increase in the number of sources of electromagnetic fields in daily life and occupational circumstances.
To date it remains unclear whether patients are at risk of device failure when being subjected to these fields. There are currently no general guidelines available to help clinicians informing their patients about safety levels and behavior around these electromagnetic fields.
Read more
This study aims to identify the thresholds of safe use of these devices and potential failures under worst-case conditions in 50/60 Hz fields (i.e.
power line frequency). Device implanted patients will be exposed to electric, magnetic and combined fields of different intensity at various device programming (e.g. nominal and maximum sensitivity). The results will show whether patients are safe in public or occupational environments, which medical relevant disturbances can occur and if a correlation exists between disturbances and device type or patients physique.
- Conditions
- Disorder of Cardiac Pacemaker System, Disorder of Implantable Defibrillator, Cardiac Arrhythmia
- Being tested
- Magnetic and electric field´s impact on the implant
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic and electric field´s impact on the implantDevice
Also called Examination
Examination of magnetic and electric field's impact on the implant regarding: stability detection threshold using different strength of magnetic and electric field
| Study group | Role | What they receive |
|---|---|---|
| cardiac pacemaker | Not described Receives: Device: Magnetic and electric field´s impact on the implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interference threshold of the device in electromagnetic fields in V/m and/or µT
Measured: for every patient during one ambulant visit about 1 hour study examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startSep 2009
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of Cardiac Pacemaker SystemStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Napp, MD, Principal investigator, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626261
- Sponsor's protocol ID
- 09-051
- Acronym
- FEMU
- Status last verified
- Jun 2018
- First submitted
- 20 Jun 2012
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Napp A, Joosten S, Stunder D, Knackstedt C, Zink M, Bellmann B, Marx N, Schauerte P, Silny J. Electromagnetic interference with implantable cardioverter-defibrillators at power frequency: an in vivo study. Circulation. 2014 Jan 28;129(4):441-50. doi: 10.1161/CIRCULATIONAHA.113.003081. Epub 2013 Oct 25.
PubMed 24163067
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Provocation Concerning Implants´Safety in Electronic and Magnetic Fields in Their Environment
- ClinicalTrials.gov ID
- NCT01626261
- Acronym / sponsor ID
- FEMU / 09-051
- Conditions
- Disorder of Cardiac Pacemaker System, Disorder of Implantable Defibrillator, Cardiac Arrhythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 22 Jun 2012 (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.
The number of active electrical cardiac implants such as internal cardioverter defibrillators (ICDs), pacemakers or cardiac contractility modules (CCM) has significantly risen over the last two decades. This has been paralleled by an increase in the number of sources of electromagnetic fields in daily life and occupational circumstances.
To date it remains unclear whether patients are at risk of device failure when being subjected to these fields. There are currently no general guidelines available to help clinicians informing their patients about safety levels and behavior around these electromagnetic fields.
This study aims to identify the thresholds of safe use of these devices and potential failures under worst-case conditions in 50/60 Hz fields (i.e.
power line frequency). Device implanted patients will be exposed to electric, magnetic and combined fields of different intensity at various device programming (e.g. nominal and maximum sensitivity). The results will show whether patients are safe in public or occupational environments, which medical relevant disturbances can occur and if a correlation exists between disturbances and device type or patients physique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac pacemaker | – | Device: Magnetic and electric field´s impact on the implant |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- age between 18 and 80
Key inclusion criteria (3 listed)
- men and women between 18 and 80 years
- Implantation of a Pacemaker (SM)-/ ICD-assembly at least four weeks ago
- signed informed consent
Key exclusion criteria (6 listed)
- enduring addiction of implant
- thyroid disease
- electrolyte imbalance on the trial day
- pregnancy and breastfeeding
- acute myocardial infarction (<30 days)
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 |
|---|---|---|
| Magnetic and electric field´s impact on the implantAlso: ExaminationExamination of magnetic and electric field's impact on the implant regarding: stability detection threshold using different strength of magnetic and electric field | Device | cardiac pacemaker |
Primary outcome
Interference threshold of the device in electromagnetic fields in V/m and/or µT
Time frame: for every patient during one ambulant visit about 1 hour study examination
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 15 Jun 2018.
- Derived from this study: PubMed 24163067Napp A, Joosten S, Stunder D, Knackstedt C, Zink M, Bellmann B, Marx N, Schauerte P, Silny J. Electromagnetic interference with implantable cardioverter-defibrillators at power frequency: an in vivo study. Circulation. 2014 Jan 28;129(4):441-50. doi: 10.1161/CIRCULATIONAHA.113.003081. Epub 2013 Oct 25.
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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.
Andreas Napp, MD principal investigator
University Hospital, Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder of Cardiac Pacemaker System and Disorder of Implantable Defibrillator, run by RWTH Aachen University 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 3 inclusion and 6 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 15 Jun 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?
Interference threshold of the device in electromagnetic fields in V/m and/or µT (time frame: for every patient during one ambulant visit about 1 hour study examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01626261, which also lists 1 linked publication.
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 15 Jun 2018.