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

NCT03264222 — Not applicable, Completed, 379 participants, Deutsches Herzzentrum Muenchen

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Registry	NCT03264222
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, prevention
Enrollment	379 (Actual)
Sponsor	Deutsches Herzzentrum Muenchen (Other); collaborators: Bayerisches Staatsministerium für Wirtschaft, R & S GmbH und Co KG
Conditions	Electromagnetic Interference
Interventions	Security screening procedure (Other)
Dates	start 2017-05-01, primary completion 2018-07-12, completion 2018-10-31, first posted 2017-08-29, last updated 2021-08-06
Locations	1 site in Germany

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Exposition to safety screening	Other	Other: Security screening procedure	One armed study with exposition to a new safety device (model QPS100) using radiofrequency technology

Security screening procedure (Other): Screening procedure with security device (model QPS 100)

+Outcome measures

Primary outcomes

Electromagnetic interference [10 minutes]: Occurrence of electromagnetic interference

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* implantable pacemaker or defibrillator in situ

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Deutsches Herzzentrum München	Munich, Bavaria	Germany

+Publications

Results publication: Lennerz C, O'Connor MJ, Blazek P, Weigand S, Grebmer C, Reif S, Friedrich L, Reents T, Bourier F, Schunkert H, Deisenhofer I, Kolb C. Modern Security Screening and Electromagnetic Interference With Cardiac Implantable Electronic Devices. J Am Coll Cardiol. 2020 Mar 17;75(10):1238-1239. doi: 10.1016/j.jacc.2020.01.012. No abstract available. PMID 32164898

+Investigators

Christof Kolb, MD, Principal investigator, Deutsches Herzzentrum München

My Notes

Public

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