BIA and Cardiac Implantable Electronic Devices
Evaluation of the Impact of Bioimpedance Analysis in Patients With Cardiac Implantable Electronic Devices
2 other identifiers
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2014
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2017
CompletedFirst Submitted
Initial submission to the registry
January 26, 2017
CompletedFirst Posted
Study publicly available on registry
February 8, 2017
CompletedFebruary 8, 2017
February 1, 2017
2 years
January 26, 2017
February 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessing a change in CIEDs function while and after bioimpedance analysis
at 6 months
Secondary Outcomes (1)
Lead noise loss, over or under sensing of CIEDs
At 6 months
Study Arms (1)
Patients with cardiac implantable electronic devices
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patient having a cardiac device with or without cardiac resynchronization
- years of age and above
- Patients with no pacing-dependent status
- Patients who read, understood and signed written informed consent letter
You may not qualify if:
- Patients with acute heart failure
- Patients implanted in less than 2 months
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
Related Publications (1)
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.
PMID: 29525512DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Frédéric JEAN
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Masking Details
- open
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2017
First Posted
February 8, 2017
Study Start
March 18, 2014
Primary Completion
February 28, 2016
Study Completion
January 16, 2017
Last Updated
February 8, 2017
Record last verified: 2017-02