CompletedNCT03264222Updated Aug 6, 2021

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

An interventional study of Security screening procedure in Electromagnetic Interference, sponsored by Deutsches Herzzentrum Muenchen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-06.

Sponsored by Deutsches Herzzentrum Muenchen · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 379
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

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

Read the 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.

Conditions studied

Electromagnetic Interference

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

implantable pacemaker or defibrillator in situ

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 379 participants (actual)

Study arms

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

Interventions

OtherSecurity screening procedure
Screening procedure with security device (model QPS 100)

What researchers measure

Primary outcomes

Electromagnetic interference
Occurrence of electromagnetic interference
Time frame: 10 minutes

Study locations

1 site

Deutsches Herzzentrum München
Munich, Bavaria 80636, Germany

References and documents

Publications

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. PubMed 32164898 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03264222
Lead sponsor: Deutsches Herzzentrum Muenchen
Collaborators: Bayerisches Staatsministerium für Wirtschaft, R & S GmbH und Co KG
Responsible party: Sponsor
First posted: Aug 29, 2017
Start date: May 1, 2017
Primary completion: Jul 12, 2018
Completion: Oct 31, 2018
Last update: Aug 6, 2021

Study contacts

Christof Kolb, MD

principal investigator · Deutsches Herzzentrum München

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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