Electromagnetic InterferenceNCT01369706
Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices
A study testing Hand-held metal detector in people with Electromagnetic Interference, run by Deutsches Herzzentrum Muenchen at 2 sites in 2 countries.
Trial summary
Patients with implanted pacemaker (PM) or cardioverter-defibrillator (ICD) systems are restrained in daily life by possible electromagnetic interference (EMI). Case reports suggest EMI between PM or ICD systems and hand-held metal detectors that are intensively used as part of security screening processes in e.g. 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?
- Hand-held metal detector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients presenting for routine pacemaker or cardioverter defibrillator control
- appropriate PM/ICD function
Who cannot join
- atrial or ventricular sensing abnormalities that could not be avoided by reprogramming of device parameters
- low battery status of the device such as elective replacement indicator (ERI)
- intrinsic heart rate > 120 beats per minute (bpm)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Patients with implanted pacemaker (PM) or cardioverter-defibrillator (ICD) systems are restrained in daily life by possible electromagnetic interference (EMI). Case reports suggest EMI between PM or ICD systems and hand-held metal detectors that are intensively used as part of security screening processes in e.g. airport controls.
The objective was to determine the safety of screening procedures for ferrous materials with regard to possible in vivo EMI between hand-held metal detectors and PM and ICD systems.
- Conditions
- Electromagnetic Interference
- Being tested
- Hand-held metal detector
- Keywords
- electromagnetic interference, hand-held metal detector, pacemaker, cardioverter-defibrillator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-held metal detectorDevice
2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)
| Study group | Role | What they receive |
|---|---|---|
| Hand-held metal detector | Other | Exposure to two hand-held metal detectors Receives: Device: Hand-held metal detector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromagnetic Interference
inhibition of the pacemaker, loss of capture, inappropriate mode switch, ventricular oversensing, power-on-reset, device reprogramming or loss of function
Measured: time during exposure to hand-held metal detector (2x 30 sec)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startSep 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clemens Jilek, MD, Principal investigator, Deutsches Herzzentrum MünchenChristof Kolb, MD, Study chair, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369706
- Sponsor's protocol ID
- GER-EP-007
- Status last verified
- Apr 2017
- First submitted
- 6 Jun 2011
- Last updated
- 12 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jilek C, Tzeis S, Vrazic H, Semmler V, Andrikopoulos G, Reents T, Fichtner S, Ammar S, Rassias I, Theodorakis G, Weber S, Hessling G, Deisenhofer I, Kolb C. Safety of screening procedures with hand-held metal detectors among patients with implanted cardiac rhythm devices: a cross-sectional analysis. Ann Intern Med. 2011 Nov 1;155(9):587-92. doi: 10.7326/0003-4819-155-9-201111010-00005.
PubMed 22041947
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices
- ClinicalTrials.gov ID
- NCT01369706
- Acronym / sponsor ID
- GER-EP-007
- Conditions
- Electromagnetic Interference
- Keywords
- electromagnetic interference, hand-held metal detector, pacemaker, cardioverter-defibrillator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Posted 30 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with implanted pacemaker (PM) or cardioverter-defibrillator (ICD) systems are restrained in daily life by possible electromagnetic interference (EMI). Case reports suggest EMI between PM or ICD systems and hand-held metal detectors that are intensively used as part of security screening processes in e.g. airport controls.
The objective was to determine the safety of screening procedures for ferrous materials with regard to possible in vivo EMI between hand-held metal detectors and PM and ICD systems.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hand-held metal detector | Other | Device: Hand-held metal detectorExposure to two hand-held metal detectors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presenting for routine pacemaker or cardioverter defibrillator control
- appropriate PM/ICD function
Key exclusion criteria (3 listed)
- atrial or ventricular sensing abnormalities that could not be avoided by reprogramming of device parameters
- low battery status of the device such as elective replacement indicator (ERI)
- intrinsic heart rate > 120 beats per minute (bpm)
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 |
|---|---|---|
| Hand-held metal detector2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany) | Device | Hand-held metal detector |
Primary outcome
Electromagnetic Interference
Time frame: time during exposure to hand-held metal detector (2x 30 sec)
inhibition of the pacemaker, loss of capture, inappropriate mode switch, ventricular oversensing, power-on-reset, device reprogramming or loss of function
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22041947Jilek C, Tzeis S, Vrazic H, Semmler V, Andrikopoulos G, Reents T, Fichtner S, Ammar S, Rassias I, Theodorakis G, Weber S, Hessling G, Deisenhofer I, Kolb C. Safety of screening procedures with hand-held metal detectors among patients with implanted cardiac rhythm devices: a cross-sectional analysis. Ann Intern Med. 2011 Nov 1;155(9):587-92. doi: 10.7326/0003-4819-155-9-201111010-00005.
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.
Clemens Jilek, MD principal investigator
Deutsches Herzzentrum München
Christof Kolb, MD study chair
Deutsches Herzzentrum München
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand-held metal detector in people with Electromagnetic Interference, run by Deutsches Herzzentrum Muenchen at 2 sites in 2 countries.
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 2 inclusion and 3 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 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Greece. 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?
Yes. Results are posted in the registry (first posted 30 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: time during exposure to hand-held metal detector (2x 30 sec)). 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 NCT01369706, 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 12 Apr 2017.