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OpenTrials
Completed

NCT Number: NCT03264222

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deutsches Herzzentrum München

Munich, Bavaria, 80636, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • implantable pacemaker or defibrillator in situ

Exclusion criteria

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

Treatment and study plan

Security screening procedure

Other

Screening procedure with security device (model QPS 100)

Primary outcomes

  1. Electromagnetic interference

    Time frame: 10 minutes

    Occurrence of electromagnetic interference

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Collaborators

  • Bayerisches Staatsministerium für Wirtschaft
  • R & S GmbH und Co KG

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 29, 2017
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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