Evaluation of the Impact of Bioimpedance Analysis in Patients With Cardiac Implantable Electronic Devices
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Assessing a change in CIEDs function while and after bioimpedance analysis
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Masking Description
open
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients with cardiac implantable electronic devices
Intervention: Bioimpedance analysis (Drug)
Outcomes
Primary Outcomes
Assessing a change in CIEDs function while and after bioimpedance analysis
Time Frame: at 6 months
Secondary Outcomes
- Lead noise loss, over or under sensing of CIEDs(At 6 months)