Evaluation of Interference Between Bioelectrical Impedance Analysis and Implantable Cardioverter Defibrillators

Electromagnetic Interference Clinical Trial

Official title:

Use of Bioelectrical Impedance Analysis in the Nutritional Assessment of Patients With CHF Equipped With Implantable Cardioverter Defibrillators

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02349737
• Other study ID #: Quality control study
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2015
• Last updated: January 28, 2015
• Start date: October 2014

Study information

• Verified date: January 2015
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Implantation with a wireless-enabled ICD

Exclusion Criteria:

• Age <18yrs

• Inability to sign an informed consent

• Pacemaker dependancy

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Electromagnetic Interference

Intervention

Other:
• Exposure to BIA interference with the ICD
Exposure to BIA interference with the ICD

Locations

Country	Name	City	State
Switzerland	University Hospital Geneva	Geneva 14

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who have electromagnetic interference of the ICD when exposed to BIA.		5-10 minutes	No