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

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).

Study Overview

• Status: Completed
• Conditions: Bradycardia, Atrial Tachyarrhythmia
• Intervention / Treatment: Device: Use of a Tablet; Device: Use of a Smart Phone

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Participants with MICRA Device; 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; 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).; Device: Use of a Smart Phone; 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).

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Emory University

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): October 24, 2016
• Study Completion (Actual): October 24, 2016

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: April 29, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: October 9, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Tablet; Bradycardia; Atrial Tachyarrhythmia; Smart Phone
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Bradycardia; Tachycardia
• Other Study ID Numbers: IRB00084576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO