BIA and Cardiac Implantable Electronic Devices

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03045822

Enrollment

200

Registered

2017-02-08

Start date

2014-03-18

Completion date

2017-01-16

Last updated

2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Performing Bioimpedance Analysis

Keywords

Bioimpedance analysis, implantable cardioverter-defibrillators, pacemakers

Brief summary

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.

Detailed description

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.

Interventions

DRUGBioimpedance analysis

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Masking description

open

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Assessing a change in CIEDs function while and after bioimpedance analysis	at 6 months

Secondary

Measure	Time frame
Lead noise loss, over or under sensing of CIEDs	At 6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026