CClinicalTrials.gg
Status unknownNCT02349737Updated Jan 29, 2015

Evaluation of Interference Between Bioelectrical Impedance Analysis and Implantable Cardioverter Defibrillators

An observational study in Electromagnetic Interference, sponsored by University Hospital, Geneva. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-29.

Sponsored by University Hospital, Geneva · Observational

The sponsor has not verified this record recently (last verified Jan 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
70
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Electromagnetic Interference

Keywords

  • Bioelectrical Impedance Analysis
  • Body composition
  • ICD
03

In context

Lead sponsor

University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with ICD.

Inclusion criteria

  • Implantation with a wireless-enabled ICD

Exclusion criteria

Exclusion Criteria:

  • Age \<18yrs
  • Inability to sign an informed consent
  • Pacemaker dependancy
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • Electromagnetic Interference

    Other: Exposure to BIA interference with the ICD

Interventions

  • OtherExposure to BIA interference with the ICD

    Exposure to BIA interference with the ICD

    Also known as: Study group

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What researchers measure

Primary outcomes

  1. Number of patients who have electromagnetic interference of the ICD when exposed to BIA.

    Time frame: 5-10 minutes

07

Study locations

1 of 1 sites recruiting
  • University Hospital Geneva
    Geneva 14, 1211, Switzerland
    • Philippe Meyer, MD · Contact · +41223727225
    Recruiting
08

References and documents

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 22452409 ↗
  • Meyer 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02349737
Lead sponsor
University Hospital, Geneva
Responsible party
Philippe Meyer (MD, University Hospital, Geneva) — Principal investigator
First posted
Jan 29, 2015
Start date
Oct 2014
Primary completion
Jan 2015
Last update
Jan 29, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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