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

Not Applicable

Completed

• Conditions: Electromagnetic Interference
• Interventions: Device: Hand-held metal detector

• Registration Number: NCT01369706
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-06-06
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-09
• Results First Submitted: 2015-10-27
• Results First Submitted QC: 2015-10-27
• Results First Posted: 2015-11-30
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 388

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hand-held metal detector	Hand-held metal detector	Exposure to two hand-held metal detectors

Primary Outcome Measures

Name	Time	Method
Electromagnetic Interference	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

Trial Locations

Locations (2)

Deutsches Herzzentrum München; 🇩🇪 München, Germany

Cardiology Department, Hospital "Henry Dunant"; 🇬🇷 Athens, Greece