BIA and Cardiac Implantable Electronic Devices

Performing Bioimpedance Analysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045822
• Other study ID #: CHU-302
• Secondary ID: 2013-A01060-45
• Status: Completed
• Phase: Phase 4
• First received: January 26, 2017
• Last updated: February 3, 2017
• Start date: March 18, 2014
• Est. completion date: January 16, 2017

Study information

• Verified date: February 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 16, 2017
• Est. primary completion date: February 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Performing Bioimpedance Analysis

Intervention

Drug:
• Bioimpedance analysis

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing a change in CIEDs function while and after bioimpedance analysis		at 6 months
Secondary	Lead noise loss, over or under sensing of CIEDs		At 6 months