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

July 31, 2021 updated by: Deutsches Herzzentrum Muenchen
Patients with implantable cardiac electronic devices will be exposed to a new safety device and evaluated for potential electromagnetic interference.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

379

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80636
        • Deutsches Herzzentrum München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Exposition to safety screening
One armed study with exposition to a new safety device (model QPS100) using radiofrequency technology
Other: Security screening procedure
Screening procedure with security device (model QPS 100)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromagnetic interference
Time Frame: 10 minutes
Occurrence of electromagnetic interference
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Collaborators

Bayerisches Staatsministerium für Wirtschaft
R & S GmbH und Co KG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2017

Primary Completion (ACTUAL)

July 12, 2018

Study Completion (ACTUAL)

October 31, 2018

Study Registration Dates

First Submitted

June 26, 2017

First Submitted That Met QC Criteria

August 24, 2017

First Posted (ACTUAL)

August 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2021

Last Update Submitted That Met QC Criteria

July 31, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • GER-EP-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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