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

German Heart Center Munich

Status: Completed

Conditions: Electromagnetic Interference

Treatments: Device: Hand-held metal detector

Study type: Interventional

Funder types: Other

Identifiers

NCT01369706

GER-EP-007

Details and patient eligibility

About

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.

Enrollment: 388 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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388 participants in 1 patient group

Hand-held metal detector

Other group

Description:

Exposure to two hand-held metal detectors

Treatment:

Device: Hand-held metal detector