Evaluation of Interference Between Bioelectrical Impedance Analysis and Implantable Cardioverter Defibrillators
- Conditions
- Electromagnetic Interference
- Interventions
- Other: Exposure to BIA interference with the ICD
- Registration Number
- NCT02349737
- Lead Sponsor
- University Hospital, Geneva
- Brief Summary
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- Implantation with a wireless-enabled ICD
- Age <18yrs
- Inability to sign an informed consent
- Pacemaker dependancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Electromagnetic Interference Exposure to BIA interference with the ICD -
- Primary Outcome Measures
Name Time Method Number of patients who have electromagnetic interference of the ICD when exposed to BIA. 5-10 minutes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Geneva
🇨ðŸ‡Geneva 14, Switzerland