Safety of Smartphones Among Patients With Cardiac Implantable Electronic Devices

February 12, 2015 updated by: Deutsches Herzzentrum Muenchen

Over the past year smartphones have developed from a niche product to a commoditized product and are now squeezing classic mobile phones out of market. According to a survey a quarter of the German population is making use of a smartphone at present.

An interference between smartphones and the functionality of pacemakers or implantable defibrillators is rather unlikely but cannot entirely be excluded. A systematic study regarding a possible interference between smartphones and modern pacemaker- and ICD-system with a better shielding against external influence has not taken place so far. In this study the investigators intend to investigate any interference between different smartphones produced by different manufacturers and diverse cardiovascular implanted electronic devices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

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
    • Bayern
      • München, Bayern, Germany, 80636
        • Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

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

Sampling Method

Non-Probability Sample

Study Population

Recipients of implantable pacemakers or defibrillators

Description

Inclusion Criteria:

  • Presence of an implantable pacemaker or defibrillator

Exclusion Criteria:

  • Lead malfunction which can not reprogrammed
  • Battery depletion

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pacemakers and defibrillators
Drug: Pacemaker and defibrillator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interference of smartphones with cardiac implantable electronic devices
Time Frame: acute study (no follow-up)
Interference testing will be performed during routine follow-up of pacemakers or defibrillators and potential interference will be recorded by ECG.
acute study (no follow-up)

Collaborators and Investigators

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

Sponsor

Deutsches Herzzentrum Muenchen

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

February 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

February 28, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

March 28, 2013

Study Record Updates

Last Update Posted (Estimate)

February 13, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • GER-EP-009

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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