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

This study has been completed.
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01369706
First received: June 6, 2011
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Electromagnetic Interference
Device: Hand-held metal detector

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Electromagnetic interference [ Time Frame: time during exposure to hand-held metal detector (2x 30 sec) ] [ Designated as safety issue: Yes ]
    inhibition of the pacemaker, loss of capture, inappropriate mode switch, ventricular oversensing, power-on-reset, device reprogramming or loss of function


Enrollment: 388
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Hand-held metal detector
Exposure to two hand-held metal detectors
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369706

Locations
Germany
Deutsches Herzzentrum München
München, Germany, 80636
Greece
Cardiology Department, Hospital "Henry Dunant"
Athens, Greece
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Principal Investigator: Clemens Jilek, MD Deutsches Herzzentrum München
Study Chair: Christof Kolb, MD Deutsches Herzzentrum München
  More Information

Publications:
Responsible Party: Deutsches Herzzentrum - Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München
ClinicalTrials.gov Identifier: NCT01369706     History of Changes
Other Study ID Numbers: EP-007
Study First Received: June 6, 2011
Last Updated: February 28, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:
electromagnetic interference
hand-held metal detector
pacemaker
cardioverter-defibrillator

ClinicalTrials.gov processed this record on July 24, 2014