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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand-held metal detector | Other | Exposure to two hand-held metal detectors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clemens Jilek, MD | Deutsches Herzzentrum München | Principal Investigator |
| Christof Kolb, MD | Deutsches Herzzentrum München | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum München | München | 80636 | Germany | |||
| Cardiology Department, Hospital "Henry Dunant" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22041947 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Electromagnetic Interference | inhibition of the pacemaker, loss of capture, inappropriate mode switch, ventricular oversensing, power-on-reset, device reprogramming or loss of function | Electromagnetic interference | Posted | Number | participants | time during exposure to hand-held metal detector (2x 30 sec) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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Convenience sample of patients
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Christof Kolb | Deutsches Herzzentrum München | +49891218 | 2020 | kolb@dhm.mhn.de |
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| Athens |
| Greece |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Participants |
|
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| 0 |
| 388 |
| 0 |
| 388 |
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