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

NCT ID: NCT03264222

Last Updated: 2021-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

379 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-10-31

Brief Summary

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

Detailed Description

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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

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Electromagnetic Interference

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective cohort study.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exposition to safety screening

One armed study with exposition to a new safety device (model QPS100) using radiofrequency technology

Group Type OTHER

Security screening procedure

Intervention Type OTHER

Screening procedure with security device (model QPS 100)

Interventions

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Security screening procedure

Screening procedure with security device (model QPS 100)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* implantable pacemaker or defibrillator in situ

Exclusion Criteria

* malfunction of implantable pacemaker or defibrillator
* low battery voltage of implanted cardiac electronic device
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayerisches Staatsministerium für Wirtschaft

UNKNOWN

Sponsor Role collaborator

R & S GmbH und Co KG

UNKNOWN

Sponsor Role collaborator

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christof Kolb, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum München

Locations

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Deutsches Herzzentrum München

Munich, Bavaria, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 32164898 (View on PubMed)

Other Identifiers

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GER-EP-017

Identifier Type: -

Identifier Source: org_study_id

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