Recipients of Implantable Pacemakers or DefibrillatorsNCT01819896
Safety of Smartphones Among Patients With Cardiac Implantable Electronic Devices
An observational study of Recipients of Implantable Pacemakers or Defibrillators, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recipients of Implantable Pacemakers or Defibrillators
- What is being tested?
- Pacemaker and defibrillator
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recipients of implantable pacemakers or defibrillators
Who may be able to join
- Presence of an implantable pacemaker or defibrillator
Who cannot join
- Lead malfunction which can not reprogrammed
- Battery depletion
Trial locations and contacts
1 site in 1 country.
Germany1 site
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
München, Bavaria, 80636
About this study
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.
- Being tested
- Pacemaker and defibrillator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker and defibrillatorDrug
| Study group | Role | What they receive |
|---|---|---|
| pacemakers and defibrillators | Not described Receives: Drug: Pacemaker and defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interference of smartphones with cardiac implantable electronic devices
Interference testing will be performed during routine follow-up of pacemakers or defibrillators and potential interference will be recorded by ECG.
Measured: acute study (no follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionOct 2013
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recipients of Implantable Pacemakers or DefibrillatorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819896
- Sponsor's protocol ID
- GER-EP-009
- Status last verified
- Feb 2015
- First submitted
- 28 Feb 2013
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Smartphones Among Patients With Cardiac Implantable Electronic Devices
- ClinicalTrials.gov ID
- NCT01819896
- Acronym / sponsor ID
- GER-EP-009
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pacemakers and defibrillators | – | Drug: Pacemaker and defibrillator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recipients of implantable pacemakers or defibrillators
Key inclusion criteria (1 listed)
- Presence of an implantable pacemaker or defibrillator
Key exclusion criteria (2 listed)
- Lead malfunction which can not reprogrammed
- Battery depletion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker and defibrillator | Drug | pacemakers and defibrillators |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recipients of Implantable Pacemakers or Defibrillators, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interference of smartphones with cardiac implantable electronic devices (time frame: acute study (no follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2015.