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

Not Applicable

Completed

• Conditions: Electromagnetic Interference
• Interventions: Other: Security screening procedure

• Registration Number: NCT03264222
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-08-24
• Study First Posted: 2017-08-29
• Primary Completion: 2018-07-12
• Study Completion: 2018-10-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-31
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 379

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Electromagnetic interference	10 minutes	Occurrence of electromagnetic interference

Trial Locations

Locations (1)

Deutsches Herzzentrum München; 🇩🇪 Munich, Bavaria, Germany