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OpenTrials
Completed

NCT Number: NCT03045822

BIA and Cardiac Implantable Electronic Devices

There are an increase number of patients with cardiac implantable electronic devices (CIEDs) such as pacemakers (PM) and implantable cardioverter-defibrillators (ICDs) worldwide. The current medical practice guidelines warn on performing bioimpedance analysis (BIA) in this group of patients to avoid any electromagnetic interference. These recommendations restrict the use of BIA in many patients with heart failure in whom BIA might be of great interest in detecting peripheral congestion and in guidance of treatment. However, it is not well known whether BIA can affect the function of cardiac devices. Investigators aimed to test the incidence of electromagnetic interference between BIA and CIEDs.

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Key information

Conditions

Performing Bioimpedance Analysis

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

Patients enrollment were during routine face-to-face consultations, scheduled for PM and ICDs interrogations. Investigators recorded before and after each BIA measure, the battery voltage of the device, lead impedance and stimulation thresholds. The device electrograms were monitored during BIA measurements to detect any electromagnetic interference or oversensing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient having a cardiac device with or without cardiac resynchronization
  • 18 years of age and above
  • Patients with no pacing-dependent status
  • Patients who read, understood and signed written informed consent letter

Exclusion criteria

  • Patients with acute heart failure
  • Patients implanted in less than 2 months
  • Dysfunction of the device in a follow-up visit or in the inclusion visit
  • Patients with a particular device lead model prone to develop electronical problems such as Sprint Fidelis of Medtronic (Minneapolis, USA) or Riata of St. Jude Medical (St. Paul, USA)
  • Pregnancy

Treatment and study plan

Bioimpedance analysis

Drug

Primary outcomes

  1. Assessing a change in CIEDs function while and after bioimpedance analysis

    Time frame: at 6 months

Secondary outcomes

  1. Lead noise loss, over or under sensing of CIEDs

    Time frame: At 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Evaluation of the Impact of Bioimpedance Analysis in Patients With Cardiac Implantable Electronic Devices

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Feb 8, 2017
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.