Evaluation of Interference Between Bioelectrical Impedance Analysis and Implantable Cardioverter Defibrillators

University Hospitals (UH)

Status: Unknown

Conditions: Electromagnetic Interference

Treatments: Other: Exposure to BIA interference with the ICD

Study type: Observational

Funder types: Other

Identifiers

NCT02349737

Quality control study

Details and patient eligibility

About

Evaluation of electromagnetic interference between Bioelectrical Impedance Analysis (BIA) and implantable cardioverter defibrillators (ICDs).

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Implantation with a wireless-enabled ICD

Exclusion criteria

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

Trial design

70 participants in 1 patient group

Electromagnetic Interference

Treatment:

Other: Exposure to BIA interference with the ICD