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

NCT01626261 | Completed

• 1 other identifier: 09-051
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Disorder of Cardiac Pacemaker System; Disorder of Implantable Defibrillator; Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

cardiac pacemaker

Device: Magnetic and electric field´s impact on the implant

Interventions

Magnetic and electric field´s impact on the implant DEVICE

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

Also known as: Examination

cardiac pacemaker

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

age between 18 and 80

You may qualify if:

• men and women between 18 and 80 years
• Implantation of a Pacemaker (SM)-/ ICD-assembly at least four weeks ago
• signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Universtiy Hospital RWTH Aachen

Aachen, Northrhine-Westfalia, 52074, Germany

Location

Related Publications (1)

• Napp A, Joosten S, Stunder D, Knackstedt C, Zink M, Bellmann B, Marx N, Schauerte P, Silny J. Electromagnetic interference with implantable cardioverter-defibrillators at power frequency: an in vivo study. Circulation. 2014 Jan 28;129(4):441-50. doi: 10.1161/CIRCULATIONAHA.113.003081. Epub 2013 Oct 25.

  PMID: 24163067 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood (serum and plasma) urine

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Andreas Napp, MD

  University Hospital, Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 22, 2012
• Study Start: September 1, 2009
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 15, 2018

Record last verified: 2018-06

Locations

DE (1)