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

Deutsches Herzzentrum Muenchen388 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

388

Conditions

Electromagnetic Interference

Interventions

Hand-held metal detector

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

Deutsches Herzzentrum München

München, Germany

Cardiology Department, Hospital "Henry Dunant"

Athens, Greece

Outcomes

Primary Outcomes

Electromagnetic Interference

inhibition of the pacemaker, loss of capture, inappropriate mode switch, ventricular oversensing, power-on-reset, device reprogramming or loss of function

Time frame: time during exposure to hand-held metal detector (2x 30 sec)