Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices

This study has been completed.
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen Identifier:
First received: June 6, 2011
Last updated: October 27, 2015
Last verified: October 2015

Patients with implanted pacemaker (PM) or cardioverter-defibrillator (ICD) systems are restrained in daily life by possible electromagnetic interference (EMI). Case reports suggest EMI between PM or ICD systems and hand-held metal detectors that are intensively used as part of security screening processes in e.g. airport controls.

The objective was to determine the safety of screening procedures for ferrous materials with regard to possible in vivo EMI between hand-held metal detectors and PM and ICD systems.

Condition Intervention
Electromagnetic Interference
Device: Hand-held metal detector

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Electromagnetic Interference [ Time Frame: time during exposure to hand-held metal detector (2x 30 sec) ] [ Designated as safety issue: Yes ]
    inhibition of the pacemaker, loss of capture, inappropriate mode switch, ventricular oversensing, power-on-reset, device reprogramming or loss of function

Enrollment: 388
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Hand-held metal detector
Exposure to two hand-held metal detectors
Device: Hand-held metal detector
2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients presenting for routine pacemaker or cardioverter defibrillator control
  • appropriate PM/ICD function

Exclusion Criteria:

  • atrial or ventricular sensing abnormalities that could not be avoided by reprogramming of device parameters
  • low battery status of the device such as elective replacement indicator (ERI)
  • intrinsic heart rate > 120 beats per minute (bpm)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01369706

Deutsches Herzzentrum München
München, Germany, 80636
Cardiology Department, Hospital "Henry Dunant"
Athens, Greece
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Principal Investigator: Clemens Jilek, MD Deutsches Herzzentrum München
Study Chair: Christof Kolb, MD Deutsches Herzzentrum München
  More Information

Responsible Party: Deutsches Herzzentrum Muenchen Identifier: NCT01369706     History of Changes
Other Study ID Numbers: EP-007
Study First Received: June 6, 2011
Results First Received: October 27, 2015
Last Updated: October 27, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:
electromagnetic interference
hand-held metal detector
cardioverter-defibrillator processed this record on December 01, 2015