Bradycardia, Atrial TachyarrhythmiaMICRANCT02758210
Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)
A study testing Use of a Tablet and Use of a Smart Phone in people with Bradycardia, Atrial Tachyarrhythmia, run by Emory University at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the effects that electromagnetic field exposure from using a tablet and smart phone have on a leadless pacemaker (MICRA device). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bradycardia, Atrial Tachyarrhythmia
- What is being tested?
- Use of a Tablet and Use of a Smart Phone
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2016to 24 Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients enrolled in MICRA Study and MICRA CA study at Emory University Hospital and Emory Midtown Hospital
- Able to consent
Who cannot join
- Patients not enrolled in MICRA Study and MICRA CA study at Emory University Hospital and Emory Midtown Hospital
- Children and vulnerable populations
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
About this study
The purpose of this study is to evaluate the effects that electromagnetic field exposure from using a tablet and smart phone have on a leadless pacemaker (MICRA device).
Read the detailed description
With advancement in technology, people are exposed to new sources of electromagnetic field like tablets and smart phones. There are magnets in smart phones and tablets that could affect the functions of pacemakers. The main purpose of this study is to evaluate the effects of electromagnetic field exposure from using a tablet and a smart phone with participants that have a leadless pacemaker (MICRA device) implanted inside them. Participants will be asked to report any symptoms that they experience during the testing.
- Conditions
- Bradycardia, Atrial Tachyarrhythmia
- Being tested
- Use of a Tablet, Use of a Smart Phone
- Keywords
- Bradycardia, Atrial Tachyarrhythmia, Smart Phone, Tablet
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of a TabletDevice
Testing of the electromagnetic field exposure and it's affect on the participant's previously implanted MICRA device is assessed by interrogation of the device before using Tablet and while using the Tablet. The measured position of the Tablets tested will be normal routine position (noting at least 6 inches/15 centimeters from their pacemaker).
Use of a Smart PhoneDevice
Testing of the electromagnetic field exposure and it's affect on the participant's previously implanted MICRA device is assessed by interrogation of the device before using a Smart phone and while using the Smart phone. The position of the Smart phone tested will be normal position at the ear and while texting (noting at least 6 inches/15 centimeters from their pacemaker).
| Study group | Role | What they receive |
|---|---|---|
| Participants with MICRA Device | Experimental | Participants that received the MICRA device prior to study enrollment will have monitored use of Smart Phone and Tablet at one study visit. Electrogram printing will take place during use of each device to see if there is any pacing inhibition or asynchronous pacing. Receives: Device: Use of a Tablet; Device: Use of a Smart Phone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Response Assessed by Asynchronous Pacing When Using a Smart Phone
Cardiac pacing before and during use of a smart phone was monitored to assess asynchronous pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the smart phone usage.
Measured: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Number of Participants Experiencing Asynchronous Pacing While Using a Tablet
Cardiac pacing before and during use of a tablet were monitored to assess if there is asynchronous pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the tablet usage.
Measured: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Number of Participants Experiencing Inhibition of Ventricular Pacing While Using a Smart Phone
Ventricular pacing before and during use of a smart phone was monitored to assess the presence of inhibition of ventricular pacing due to electromagnetic field exposure. The programmed pacing of the MICRA device is specific for each participant. The individualized, initial programmed pacing settings of the MICRA device are compared to any changes during the smart phone usage.
Measured: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Device Response While Using a Tablet, Assessed by Ventricular Pacing
Ventricular pacing before and during use of a tablet was monitored to assess if there's inhibition of ventricular pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the tablet usage. The assessment of this outcome measure takes an average of 5 minutes.
Measured: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Secondary outcomes (2)
Number of Participants Reporting Clinical Symptoms While Using a Smart Phone
Participants were asked to report any clinical symptoms that they experienced when using the smart phone.
Measured: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Number of Participants Reporting Clinical Symptoms While Using a Tablet
Participants were asked to report any clinical symptoms that they experienced when using the tablet.
Measured: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startApr 2016
- Primary completion24 Oct 2016
- Study completion24 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bradycardia, Atrial TachyarrhythmiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikhael El Chami, Emory University
- Investigators
- Mikhael El Chami, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758210
- Sponsor's protocol ID
- IRB00084576
- Acronym
- MICRA
- Status last verified
- Oct 2017
- First submitted
- 19 Apr 2016
- Last updated
- 9 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)
- ClinicalTrials.gov ID
- NCT02758210
- Acronym / sponsor ID
- MICRA / IRB00084576
- Conditions
- Bradycardia, Atrial Tachyarrhythmia
- Keywords
- Bradycardia, Atrial Tachyarrhythmia, Smart Phone, Tablet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 24 Oct 2016 (actual)
- Study completion
- 24 Oct 2016 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Posted 2 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects that electromagnetic field exposure from using a tablet and smart phone have on a leadless pacemaker (MICRA device).
Detailed description
With advancement in technology, people are exposed to new sources of electromagnetic field like tablets and smart phones. There are magnets in smart phones and tablets that could affect the functions of pacemakers. The main purpose of this study is to evaluate the effects of electromagnetic field exposure from using a tablet and a smart phone with participants that have a leadless pacemaker (MICRA device) implanted inside them. Participants will be asked to report any symptoms that they experience during the testing.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with MICRA Device | Experimental | Device: Use of a Tablet, Device: Use of a Smart PhoneParticipants that received the MICRA device prior to study enrollment will have monitored use of Smart Phone and Tablet at one study visit. Electrogram printing will take place during use of each device to see if there is any pacing inhibition or asynchronous pacing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients enrolled in MICRA Study and MICRA CA study at Emory University Hospital and Emory Midtown Hospital
- Able to consent
Key exclusion criteria (2 listed)
- Patients not enrolled in MICRA Study and MICRA CA study at Emory University Hospital and Emory Midtown Hospital
- Children and vulnerable populations
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 |
|---|---|---|
| Use of a TabletTesting of the electromagnetic field exposure and it's affect on the participant's previously implanted MICRA device is assessed by interrogation of the device before using Tablet and while using the Tablet. The measured position of the Tablets tested will be normal routine position (noting at least 6 inches/15 centimeters from their pacemaker). | Device | Participants with MICRA Device |
| Use of a Smart PhoneTesting of the electromagnetic field exposure and it's affect on the participant's previously implanted MICRA device is assessed by interrogation of the device before using a Smart phone and while using the Smart phone. The position of the Smart phone tested will be normal position at the ear and while texting (noting at least 6 inches/15 centimeters from their pacemaker). | Device | Participants with MICRA Device |
Primary outcome
Device Response Assessed by Asynchronous Pacing When Using a Smart Phone
Time frame: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Cardiac pacing before and during use of a smart phone was monitored to assess asynchronous pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the smart phone usage.
Number of Participants Experiencing Asynchronous Pacing While Using a Tablet
Time frame: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Cardiac pacing before and during use of a tablet were monitored to assess if there is asynchronous pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the tablet usage.
Number of Participants Experiencing Inhibition of Ventricular Pacing While Using a Smart Phone
Time frame: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Ventricular pacing before and during use of a smart phone was monitored to assess the presence of inhibition of ventricular pacing due to electromagnetic field exposure. The programmed pacing of the MICRA device is specific for each participant. The individualized, initial programmed pacing settings of the MICRA device are compared to any changes during the smart phone usage.
Device Response While Using a Tablet, Assessed by Ventricular Pacing
Time frame: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Ventricular pacing before and during use of a tablet was monitored to assess if there's inhibition of ventricular pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the tablet usage. The assessment of this outcome measure takes an average of 5 minutes.
2 secondary outcomes
Number of Participants Reporting Clinical Symptoms While Using a Smart Phone
Time frame: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Number of Participants Reporting Clinical Symptoms While Using a Tablet
Time frame: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Mikhael El Chami, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of a Tablet and Use of a Smart Phone in people with Bradycardia, Atrial Tachyarrhythmia, run by Emory University at 2 sites in United States.
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 2 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 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 2 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Device Response Assessed by Asynchronous Pacing When Using a Smart Phone (time frame: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)). The study lists 4 primary outcomes in all. 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 9 Nov 2017.