Electromagnetic InterferenceNCT02330900
Evaluation of Interference Between Cell Phones and Implantable Cardioverter Defibrillators
A study testing Study group in people with Electromagnetic Interference, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Evaluation of electromagnetic interference between modern cell phones and contemporary implantable cardioverter defibrillators (ICDs) 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?
- Study group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to Jan 2015
- 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
- Implantation with a wireless-enabled ICD
Who cannot join
- Age <18yrs
- inability to sign an informed consent
- pacemaker dependancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Geneva
Geneva, Canton of Geneva, 1211
About this study
Evaluation of electromagnetic interference between modern cell phones and contemporary implantable cardioverter defibrillators (ICDs)
Read the detailed description
Electrograms of ICDs will be analyzed during wireless telemetry and during exposure to an activated cell phone. ICD therapy will have been temporarily inactivated before exposure to cell phones to avoid inappropriate shocks, and the sensitivity level of the ICD will be set to maximum. The cell phones will be held over the ICD generator, as well as in the parasternar region (close to the ICD lead, which senses the signals).
Interference will be assessed by the presence of visible artefacts on the real-time electrogram, with ICD marker annotations showing atrial and/or ventricular sensed episodes. The outcome measure will be the number and proportion of patients who have electromagnetic interference of the ICD when exposed to cell phones.
The procedure will take approximately 5-10minutes, with reprogramming of the device at the end of the test. No further follow-up in the context of the study will be performed.
- Conditions
- Electromagnetic Interference
- Being tested
- Study group
- Keywords
- Implantable cardioverter defibrillator, Electromagnetic interference, Cell phone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study groupOther
Exposure to cell phone interference of the ICD
| Study group | Role | What they receive |
|---|---|---|
| Study group | No intervention | Evaluation of interference Receives: Other: Study group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who have electromagnetic interference of the ICD when exposed to cell phones.
Detection of electromagnetic interference
Measured: 5-10minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionJan 2015
- Study completionJan 2015
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.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haran Burri, MD, University Hospital, Geneva
- Investigators
- Haran Burri, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330900
- Sponsor's protocol ID
- 14-245
- Status last verified
- May 2016
- First submitted
- 25 Nov 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Burri H, Mondouagne Engkolo LP, Dayal N, Etemadi A, Makhlouf AM, Stettler C, Trentaz F. Low risk of electromagnetic interference between smartphones and contemporary implantable cardioverter defibrillators. Europace. 2016 May;18(5):726-31. doi: 10.1093/europace/euv374. Epub 2016 Feb 8.
PubMed 26857191
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Interference Between Cell Phones and Implantable Cardioverter Defibrillators
- ClinicalTrials.gov ID
- NCT02330900
- Acronym / sponsor ID
- 14-245
- Conditions
- Electromagnetic Interference
- Keywords
- Implantable cardioverter defibrillator, Electromagnetic interference, Cell phone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 5 Jan 2015 (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.
Evaluation of electromagnetic interference between modern cell phones and contemporary implantable cardioverter defibrillators (ICDs)
Detailed description
Electrograms of ICDs will be analyzed during wireless telemetry and during exposure to an activated cell phone. ICD therapy will have been temporarily inactivated before exposure to cell phones to avoid inappropriate shocks, and the sensitivity level of the ICD will be set to maximum. The cell phones will be held over the ICD generator, as well as in the parasternar region (close to the ICD lead, which senses the signals).
Interference will be assessed by the presence of visible artefacts on the real-time electrogram, with ICD marker annotations showing atrial and/or ventricular sensed episodes. The outcome measure will be the number and proportion of patients who have electromagnetic interference of the ICD when exposed to cell phones.
The procedure will take approximately 5-10minutes, with reprogramming of the device at the end of the test. No further follow-up in the context of the study will be performed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | No intervention | Other: Study groupEvaluation of interference |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Implantation with a wireless-enabled ICD
Key exclusion criteria (3 listed)
- Age <18yrs
- inability to sign an informed consent
- pacemaker dependancy
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 |
|---|---|---|
| Study groupExposure to cell phone interference of the ICD | Other | Study group |
Primary outcome
Number of patients who have electromagnetic interference of the ICD when exposed to cell phones.
Time frame: 5-10minutes
Detection 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 12 May 2016.
- Derived from this study: PubMed 26857191Burri H, Mondouagne Engkolo LP, Dayal N, Etemadi A, Makhlouf AM, Stettler C, Trentaz F. Low risk of electromagnetic interference between smartphones and contemporary implantable cardioverter defibrillators. Europace. 2016 May;18(5):726-31. doi: 10.1093/europace/euv374. Epub 2016 Feb 8.
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.
Haran Burri, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study group in people with Electromagnetic Interference, run by University Hospital, Geneva at 1 site in Switzerland.
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 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 May 2016. 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 Switzerland. 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?
Number of patients who have electromagnetic interference of the ICD when exposed to cell phones. (time frame: 5-10minutes). 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 NCT02330900, 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 May 2016.