Clinical trial NCT03045822: BIA and Cardiac Implantable Electronic Devices
Official title: Evaluation of the Impact of Bioimpedance Analysis in Patients With Cardiac Implantable Electronic Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Performing Bioimpedance Analysis
Keywords: Bioimpedance analysis
implantable cardioverter-defibrillators
pacemakers
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessing a change in CIEDs function while and after bioimpedance analysis
timeFrame: at 6 months
Secondary outcomes:
measure: Lead noise loss, over or under sensing of CIEDs
timeFrame: At 6 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Frédéric JEAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chabin X, Taghli-Lamallem O, Mulliez A, Bordachar P, Jean F, Futier E, Massoullie G, Andonache M, Souteyrand G, Ploux S, Boirie Y, Richard R, Citron B, Lusson JR, Godet T, Pereira B, Motreff P, Clerfond G, Eschalier R. Bioimpedance analysis is safe in patients with implanted cardiac electronic devices. Clin Nutr. 2019 Apr;38(2):806-811. doi: 10.1016/j.clnu.2018.02.029. Epub 2018 Mar 2.