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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01626261
First received: June 20, 2012
Last updated: April 30, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention
Disorder of Cardiac Pacemaker System
Disorder of Implantable Defibrillator
Cardiac Arrhythmia
Device: Magnetic and electric field´s impact on the implant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Provocation Concerning Implants´Safety in Electronic and Magnetic Fields in Their Environment

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Interference threshold of the device in electromagnetic fields in V/m and/or µT [ Time Frame: for every patient during one ambulant visit about 1 hour study examination ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood (serum and plasma) urine


Estimated Enrollment: 200
Study Start Date: September 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
cardiac pacemaker 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
Other Name: Examination

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

age between 18 and 80

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626261

Contacts
Contact: Andreas Napp, MD +49241800 anapp@ukaachen.de
Contact: Nikolaus Marx, MD +49241800 nmarx@ukaachen.de

Locations
Germany
Universtiy Hospital of Aachen Recruiting
Aachen, Northrhine-Westfalia, Germany, 52074
Contact: Andreas Napp, MD    +49241800    anapp@ukaachen.de   
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Andreas Napp, MD University Hospital, Aachen
  More Information

No publications provided by RWTH Aachen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01626261     History of Changes
Other Study ID Numbers: 09-051
Study First Received: June 20, 2012
Last Updated: April 30, 2015
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 03, 2015