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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Electromagnetic Interference

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Hand-held metal detector

Exposure to two hand-held metal detectors

Group Type OTHER

Hand-held metal detector

Intervention Type DEVICE

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

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No