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OpenTrials
Completed

NCT Number: NCT01369706

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

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.

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Key information

Conditions

Electromagnetic Interference

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deutsches Herzzentrum München, München, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hand-held metal detector

Device

2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 9, 2011
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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