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

NCT01369706 | Completed Results

• 1 other identifier: GER-EP-007
• Study Type: interventional
• Target: 388
• Locations: 2 countries
• Sites: 2

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.

Conditions

Electromagnetic Interference

Keywords

electromagnetic interference; hand-held metal detector; pacemaker; cardioverter-defibrillator

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Hand-held metal detector

OTHER

Exposure to two hand-held metal detectors

Device: Hand-held metal detector

Interventions

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)

Hand-held metal detector

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting for routine pacemaker or cardioverter defibrillator control
• appropriate PM/ICD function

You may not qualify if:

• 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)

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (2)

Deutsches Herzzentrum München

München, 80636, Germany

Location

Cardiology Department, Hospital "Henry Dunant"

Athens, Greece

Location

Related 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 cardiac rhythm devices: a cross-sectional analysis. Ann Intern Med. 2011 Nov 1;155(9):587-92. doi: 10.7326/0003-4819-155-9-201111010-00005.

  PMID: 22041947 RESULT

Limitations and Caveats

Convenience sample of patients

Results Point of Contact

• Title: Prof. Dr. Christof Kolb
• Organization: Deutsches Herzzentrum München

kolb@dhm.mhn.de

+49891218

Study Officials

• Clemens Jilek, MD

  Deutsches Herzzentrum München

  PRINCIPAL INVESTIGATOR

• Christof Kolb, MD

  Deutsches Herzzentrum München

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 9, 2011
• Study Start: September 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 12, 2017
• Results First Posted: November 30, 2015

Record last verified: 2017-04

Locations

DE (1); GR (1)