BIA and Cardiac Implantable Electronic Devices

University Hospital, Clermont-Ferrand

Status and phase

Completed

Phase 4

Conditions

Performing Bioimpedance Analysis

Treatments

Drug: Bioimpedance analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT03045822

CHU-302

2013-A01060-45 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Volunteers

No 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