Electromagnetic InterferenceNCT02349737
Evaluation of Interference Between Bioelectrical Impedance Analysis and Implantable Cardioverter Defibrillators
An observational study of Electromagnetic Interference, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Evaluation of electromagnetic interference between Bioelectrical Impedance Analysis (BIA) and 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?
- Exposure to BIA interference with the ICD
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2014to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ICD.
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, 1 recruiting
- Recruiting
University Hospital Geneva
Geneva, 1211
Philippe Meyer, MD, +41223727225
About this study
Official title: Use of Bioelectrical Impedance Analysis in the Nutritional Assessment of Patients With CHF Equipped With Implantable Cardioverter Defibrillators
Evaluation of electromagnetic interference between Bioelectrical Impedance Analysis (BIA) and implantable cardioverter defibrillators (ICDs).
Read the detailed description
Electrograms of ICDs will be analyzed during wireless telemetry and during body composition measurement using BIA. ICD therapy will have been temporarily inactivated before the measurement to avoid inappropriate shocks, and the sensitivity level of the ICD will be set to maximum. Body composition will be measured at three frequencies (5 khz, 50 khz and 100 khz).
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 interferences of the ICD when BIA is done.
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
- Exposure to BIA interference with the ICD
- Keywords
- Bioelectrical Impedance Analysis, Body composition, ICD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to BIA interference with the ICDOther
Also called Study group
Exposure to BIA interference with the ICD
| Study group | Role | What they receive |
|---|---|---|
| Electromagnetic Interference | Not described Receives: Other: Exposure to BIA interference with the ICD |
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 BIA.
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Meyer, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349737
- Sponsor's protocol ID
- Quality control study
- Status last verified
- Jan 2015
- First submitted
- 23 Jan 2015
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Buch E, Bradfield J, Larson T, Horwich T. Effect of bioimpedance body composition analysis on function of implanted cardiac devices. Pacing Clin Electrophysiol. 2012 Jun;35(6):681-4. doi: 10.1111/j.1540-8159.2012.03377.x. Epub 2012 Mar 27.
PubMed 22452409Meyer P, Makhlouf AM, Mondouagne Engkolo LP, Trentaz F, Thibault R, Pichard C, Burri H. Safety of Bioelectrical Impedance Analysis in Patients Equipped With Implantable Cardioverter Defibrillators. JPEN J Parenter Enteral Nutr. 2017 Aug;41(6):981-985. doi: 10.1177/0148607116633823. Epub 2016 Feb 22.
PubMed 26903305
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Bioelectrical Impedance Analysis in the Nutritional Assessment of Patients With CHF Equipped With Implantable Cardioverter Defibrillators
- ClinicalTrials.gov ID
- NCT02349737
- Acronym / sponsor ID
- Quality control study
- Conditions
- Electromagnetic Interference
- Keywords
- Bioelectrical Impedance Analysis, Body composition, ICD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2015 (actual)
- First posted
- 29 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 Bioelectrical Impedance Analysis (BIA) and implantable cardioverter defibrillators (ICDs).
Detailed description
Electrograms of ICDs will be analyzed during wireless telemetry and during body composition measurement using BIA. ICD therapy will have been temporarily inactivated before the measurement to avoid inappropriate shocks, and the sensitivity level of the ICD will be set to maximum. Body composition will be measured at three frequencies (5 khz, 50 khz and 100 khz).
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 interferences of the ICD when BIA is done.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electromagnetic Interference | – | Other: Exposure to BIA interference with the ICD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ICD.
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 |
|---|---|---|
| Exposure to BIA interference with the ICDAlso: Study groupExposure to BIA interference with the ICD | Other | Electromagnetic Interference |
Primary outcome
Number of patients who have electromagnetic interference of the ICD when exposed to BIA.
Time frame: 5-10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
- Background: PubMed 22452409Buch E, Bradfield J, Larson T, Horwich T. Effect of bioimpedance body composition analysis on function of implanted cardiac devices. Pacing Clin Electrophysiol. 2012 Jun;35(6):681-4. doi: 10.1111/j.1540-8159.2012.03377.x. Epub 2012 Mar 27.
- Derived from this study: PubMed 26903305Meyer P, Makhlouf AM, Mondouagne Engkolo LP, Trentaz F, Thibault R, Pichard C, Burri H. Safety of Bioelectrical Impedance Analysis in Patients Equipped With Implantable Cardioverter Defibrillators. JPEN J Parenter Enteral Nutr. 2017 Aug;41(6):981-985. doi: 10.1177/0148607116633823. Epub 2016 Feb 22.
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.
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 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: status not confirmed, as of the sponsor's last update on 29 Jan 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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 BIA. (time frame: 5-10 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 NCT02349737, which also lists 2 linked publications.
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 29 Jan 2015.