Electromagnetic InterferenceNCT03264222
Safety of a New Security Device in Patients With Implanted Cardiac Electronic Devices
A study testing Security screening procedure in people with Electromagnetic Interference, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
Patients with implantable cardiac electronic devices will be exposed to a new safety device and evaluated for potential electromagnetic interference. 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?
- Security screening procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2017to 31 Oct 2018
- 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
- implantable pacemaker or defibrillator in situ
Who cannot join
- malfunction of implantable pacemaker or defibrillator
- low battery voltage of implanted cardiac electronic device
Trial locations and contacts
1 site in 1 country.
About this study
Patients with implantable cardiac electronic devices will be exposed to a new safety device and evaluated for potential electromagnetic interference.
Read the detailed description
Patients with implanted pacemakers or defibrillators will undergo a screening procedure with an innovative security device. Evaluation will be made with respect to the occurrence of interference.
- Conditions
- Electromagnetic Interference
- Being tested
- Security screening procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Security screening procedureOther
Screening procedure with security device (model QPS 100)
| Study group | Role | What they receive |
|---|---|---|
| Exposition to safety screening | Other | One armed study with exposition to a new safety device (model QPS100) using radiofrequency technology Receives: Other: Security screening procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromagnetic interference
Occurrence of electromagnetic interference
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 May 2017
- Primary completion12 Jul 2018
- Study completion31 Oct 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 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study.
- Masking
- None (open label)
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- Bayerisches Staatsministerium für Wirtschaft, R & S GmbH und Co KG
- Responsible party
- Sponsor
- Investigators
- Christof Kolb, MD, Principal investigator, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264222
- Sponsor's protocol ID
- GER-EP-017
- Status last verified
- Jul 2021
- First submitted
- 26 Jun 2017
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lennerz C, O'Connor MJ, Blazek P, Weigand S, Grebmer C, Reif S, Friedrich L, Reents T, Bourier F, Schunkert H, Deisenhofer I, Kolb C. Modern Security Screening and Electromagnetic Interference With Cardiac Implantable Electronic Devices. J Am Coll Cardiol. 2020 Mar 17;75(10):1238-1239. doi: 10.1016/j.jacc.2020.01.012. No abstract available.
PubMed 32164898
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of a New Security Device in Patients With Implanted Cardiac Electronic Devices
- ClinicalTrials.gov ID
- NCT03264222
- Acronym / sponsor ID
- GER-EP-017
- Conditions
- Electromagnetic Interference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- Bayerisches Staatsministerium für Wirtschaft, R & S GmbH und Co KG
- Study start
- 1 May 2017 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 29 Aug 2017 (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.
Patients with implantable cardiac electronic devices will be exposed to a new safety device and evaluated for potential electromagnetic interference.
Detailed description
Patients with implanted pacemakers or defibrillators will undergo a screening procedure with an innovative security device. Evaluation will be made with respect to the occurrence of interference.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study.
| Arm | Type | Receives |
|---|---|---|
| Exposition to safety screening | Other | Other: Security screening procedureOne armed study with exposition to a new safety device (model QPS100) using radiofrequency technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- implantable pacemaker or defibrillator in situ
Key exclusion criteria (2 listed)
- malfunction of implantable pacemaker or defibrillator
- low battery voltage of implanted cardiac electronic device
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 |
|---|---|---|
| Security screening procedureScreening procedure with security device (model QPS 100) | Other | Exposition to safety screening |
Primary outcome
Electromagnetic interference
Time frame: 10 minutes
Occurrence of electromagnetic interference
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 6 Aug 2021.
- Derived from this study: PubMed 32164898Lennerz C, O'Connor MJ, Blazek P, Weigand S, Grebmer C, Reif S, Friedrich L, Reents T, Bourier F, Schunkert H, Deisenhofer I, Kolb C. Modern Security Screening and Electromagnetic Interference With Cardiac Implantable Electronic Devices. J Am Coll Cardiol. 2020 Mar 17;75(10):1238-1239. doi: 10.1016/j.jacc.2020.01.012. No abstract available.
- Individual participant dataSharing planned: No
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 principal investigator
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 Security screening procedure 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 2 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 6 Aug 2021. 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?
Electromagnetic interference (time frame: 10 minutes). 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 NCT03264222, 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 6 Aug 2021.