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NCT03264222 Clinical Trial

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

Electromagnetic Interference Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03264222
Other study ID # GER-EP-017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date October 31, 2018

Study information
Verified date July 2021
Source Deutsches Herzzentrum Muenchen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 379
Est. completion date October 31, 2018
Est. primary completion date July 12, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - implantable pacemaker or defibrillator in situ Exclusion Criteria: - malfunction of implantable pacemaker or defibrillator - low battery voltage of implanted cardiac electronic device

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany Deutsches Herzzentrum München Munich Bavaria

Sponsors (3)
Lead Sponsor Collaborator
Deutsches Herzzentrum Muenchen Bayerisches Staatsministerium für Wirtschaft, R & S GmbH und Co KG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Electromagnetic interference Occurrence of electromagnetic interference 10 minutes
See also
  Status Clinical Trial Phase
Completed NCT02252575 - Assessment of Electromagnetic Interference Between E-transportation and Cardiac Implantable Electronic Devices N/A
Completed NCT01369706 - Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices N/A
Recruiting NCT02349737 - Evaluation of Interference Between Bioelectrical Impedance Analysis and Implantable Cardioverter Defibrillators N/A
Completed NCT02617355 - Interference Between Surgical Magnetic Drapes and Pacemakers N/A
Recruiting NCT02330900 - Evaluation of Interference Between Cell Phones and Implantable Cardioverter Defibrillators N/A
Completed NCT03508128 - Evaluation of EMI in Patients With Micra Leadless Pacemaker