Status:

COMPLETED

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

Lead Sponsor:

Deutsches Herzzentrum Muenchen

Collaborating Sponsors:

Bayerisches Staatsministerium für Wirtschaft

R & S GmbH und Co KG

Conditions:

Electromagnetic Interference

Eligibility:

All Genders

18+ years

Phase:

NA

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.

Eligibility Criteria

Inclusion

  • implantable pacemaker or defibrillator in situ

Exclusion

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

Key Trial Info

Start Date :

May 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 31 2018

Estimated Enrollment :

379 Patients enrolled

Trial Details

Trial ID

NCT03264222

Start Date

May 1 2017

End Date

October 31 2018

Last Update

August 6 2021

Active Locations (1)

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Deutsches Herzzentrum München

Munich, Bavaria, Germany, 80636