Safety of a New Security Device in Patients With Implanted Cardiac Electronic Devices

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03264222

Enrollment

379

Registered

2017-08-29

Start date

2017-05-01

Completion date

2018-10-31

Last updated

2021-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electromagnetic Interference

Brief summary

Patients with implantable cardiac electronic devices will be exposed to a new safety device and evaluated for potential electromagnetic interference.

Detailed description

Patients with implanted pacemakers or defibrillators will undergo a screening procedure with an innovative security device. Evaluation will be made with respect to the occurrence of interference.

Interventions

OTHERSecurity screening procedure

Screening procedure with security device (model QPS 100)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Prospective cohort study.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* implantable pacemaker or defibrillator in situ

Exclusion criteria

* malfunction of implantable pacemaker or defibrillator * low battery voltage of implanted cardiac electronic device

Design outcomes

Primary

Measure	Time frame	Description
Electromagnetic interference	10 minutes	Occurrence of electromagnetic interference

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026