Examination of Implant´s Safety in an Electronic and Magnetic Field Environment

Cardiac Arrhythmia Clinical Trial

— FEMU  

Official title:

Study of Provocation Concerning Implants´Safety in Electronic and Magnetic Fields in Their Environment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626261
• Other study ID #: 09-051
• Status: Completed
• Start date: September 2009
• Est. completion date: June 2018

Study information

• Verified date: June 2018
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The number of active electrical cardiac implants such as internal cardioverter defibrillators (ICDs), pacemakers or cardiac contractility modules (CCM) has significantly risen over the last two decades. This has been paralleled by an increase in the number of sources of electromagnetic fields in daily life and occupational circumstances.

To date it remains unclear whether patients are at risk of device failure when being subjected to these fields. There are currently no general guidelines available to help clinicians informing their patients about safety levels and behavior around these electromagnetic fields.

This study aims to identify the thresholds of safe use of these devices and potential failures under worst-case conditions in 50/60 Hz fields (i.e.

power line frequency). Device implanted patients will be exposed to electric, magnetic and combined fields of different intensity at various device programming (e.g. nominal and maximum sensitivity). The results will show whether patients are safe in public or occupational environments, which medical relevant disturbances can occur and if a correlation exists between disturbances and device type or patients physique.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• men and women between 18 and 80 years

• Implantation of a Pacemaker (SM)-/ ICD-assembly at least four weeks ago

• signed informed consent

Exclusion Criteria:

• enduring addiction of implant

• thyroid disease

• electrolyte imbalance on the trial day

• pregnancy and breastfeeding

• acute myocardial infarction (<30 days)

• Comorbidity, which complicates an emergency assistance, e.g. morbus bechterew, glaucoma, micturition disturbance

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Disease
• Disorder of Cardiac Pacemaker System
• Disorder of Implantable Defibrillator

Intervention

Device:
• Magnetic and electric field´s impact on the implant
Examination of magnetic and electric field's impact on the implant regarding: stability detection threshold using different strength of magnetic and electric field

Locations

Country	Name	City	State
Germany	Universtiy Hospital RWTH Aachen	Aachen	Northrhine-Westfalia

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interference threshold of the device in electromagnetic fields in V/m and/or µT		for every patient during one ambulant visit about 1 hour study examination