Electromagnetic Interference
Conditions
Keywords
electromagnetic interference, hand-held metal detector, pacemaker, cardioverter-defibrillator
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.
Interventions
DEVICEHand-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)
Sponsors
Deutsches Herzzentrum Muenchen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electromagnetic Interference | 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 |
Countries
Germany, Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hand-held Metal Detector Exposure to two hand-held metal detectors
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) | 388 |
| Total | 388 |
Baseline characteristics
| Characteristic | Hand-held Metal Detector |
|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 15 |
| Region of Enrollment Germany | 317 participants |
| Region of Enrollment Greece | 71 participants |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 295 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 388 |
| serious Total, serious adverse events | 0 / 388 |
Outcome results
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 frame: time during exposure to hand-held metal detector (2x 30 sec)
Population: Electromagnetic interference
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hand-held Metal Detector | Electromagnetic Interference | 0 participants |