Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

BIA and Cardiac Implantable Electronic Devices

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045822
Recruitment Status : Completed
First Posted : February 8, 2017
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Performing Bioimpedance Analysis Drug: Bioimpedance analysis Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: open
Primary Purpose: Other
Official Title: Evaluation of the Impact of Bioimpedance Analysis in Patients With Cardiac Implantable Electronic Devices
Actual Study Start Date : March 18, 2014
Actual Primary Completion Date : February 28, 2016
Actual Study Completion Date : January 16, 2017

Arm Intervention/treatment
Experimental: Patients with cardiac implantable electronic devices Drug: Bioimpedance analysis



Primary Outcome Measures :
  1. Assessing a change in CIEDs function while and after bioimpedance analysis [ Time Frame: at 6 months ]

Secondary Outcome Measures :
  1. Lead noise loss, over or under sensing of CIEDs [ Time Frame: At 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045822


Locations
Layout table for location information
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Layout table for investigator information
Principal Investigator: Frédéric JEAN University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03045822    
Other Study ID Numbers: CHU-302
2013-A01060-45 ( Other Identifier: 2013-A01060-45 )
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Bioimpedance analysis
implantable cardioverter-defibrillators
pacemakers