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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01369706
First Posted: June 9, 2011
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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) ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Muenchen
ClinicalTrials.gov Identifier: NCT01369706     History of Changes
Other Study ID Numbers: GER-EP-007
First Submitted: June 6, 2011
First Posted: June 9, 2011
Results First Submitted: October 27, 2015
Results First Posted: November 30, 2015
Last Update Posted: April 12, 2017
Last Verified: April 2017

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