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).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
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).
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).
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
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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.
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
Participants were asked to report any clinical symptoms that they experienced when using the tablet.
Time frame: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)