Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)

Conditions
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Bradycardia, Atrial Tachyarrhythmia

Intervention / Treatment
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* Device: Use of a Tablet
* Device: Use of a Smart Phone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients enrolled in MICRA Study and MICRA CA study at Emory University Hospital and Emory Midtown Hospital Able to consent Exclusion Criteria: Patients not enrolled in MICRA Study and MICRA CA study at Emory University Hospital and Emory Midtown Hospital Children and vulnerable populations

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with MICRA Device<br>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. | Device: Use of a Tablet<br>* 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).<br>Device: Use of a Smart Phone<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bradycardia, Atrial Tachyarrhythmia, Smart Phone, Tablet