Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Electromagnetic Interference
- Sponsor
- Deutsches Herzzentrum Muenchen
- Enrollment
- 388
- Locations
- 2
- Primary Endpoint
- Electromagnetic Interference
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility 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)
Outcomes
Primary Outcomes
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