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

Electromagnetic Interference Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369706
• Other study ID #: GER-EP-007
• Status: Completed
• Phase: N/A
• First received: June 6, 2011
• Last updated: April 10, 2017
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2017
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Electromagnetic Interference

Intervention

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)

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum München	München
Greece	Cardiology Department, Hospital "Henry Dunant"	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Countries where clinical trial is conducted

Germany,  Greece, 

References & Publications (1)

Jilek C, Tzeis S, Vrazic H, Semmler V, Andrikopoulos G, Reents T, Fichtner S, Ammar S, Rassias I, Theodorakis G, Weber S, Hessling G, Deisenhofer I, Kolb C. Safety of screening procedures with hand-held metal detectors among patients with implanted cardia — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electromagnetic Interference	inhibition of the pacemaker, loss of capture, inappropriate mode switch, ventricular oversensing, power-on-reset, device reprogramming or loss of function	time during exposure to hand-held metal detector (2x 30 sec)