BIA and Cardiac Implantable Electronic Devices

Phase 4

Completed

• Conditions: Performing Bioimpedance Analysis
• Interventions: Drug: Bioimpedance analysis

• Registration Number: NCT03045822
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2014-03-18
• Primary Completion: 2016-02-28
• Study Completion: 2017-01-16
• Study First Submitted: 2017-01-26
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-03
• Last Update Submitted: 2017-02-03
• Study First Posted: 2017-02-08
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with cardiac implantable electronic devices	Bioimpedance analysis	-

Primary Outcome Measures

Name	Time	Method
Assessing a change in CIEDs function while and after bioimpedance analysis	at 6 months

Secondary Outcome Measures

Name	Time	Method
Lead noise loss, over or under sensing of CIEDs	At 6 months

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France