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

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ClinicalTrials.gov Identifier: NCT01369706
Recruitment Status : Completed
First Posted : June 9, 2011
Results First Posted : November 30, 2015
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

Brief Summary:

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 or disease Intervention/treatment Phase
Electromagnetic Interference Device: Hand-held metal detector Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 388 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices
Study Start Date : September 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
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)



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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369706


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

Publications of Results:
Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01369706     History of Changes
Other Study ID Numbers: GER-EP-007
First Posted: June 9, 2011    Key Record Dates
Results First Posted: November 30, 2015
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by Deutsches Herzzentrum Muenchen:
electromagnetic interference
hand-held metal detector
pacemaker
cardioverter-defibrillator