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

Not Applicable

Completed

• Conditions: Bradycardia, Atrial Tachyarrhythmia
• Interventions: Device: Use of a Tablet; Device: Use of a Smart Phone

• Registration Number: NCT02758210
• Lead Sponsor: Emory University

Brief 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).

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 Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-02
• Primary Completion: 2016-10-24
• Study Completion: 2016-10-24
• Results First Submitted: 2017-09-08
• Results First Submitted QC: 2017-09-08
• Status Verified: 2017-10
• Results First Posted: 2017-10-02
• Last Update Submitted: 2017-10-09
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients enrolled in MICRA Study and MICRA CA study at Emory University Hospital and Emory Midtown Hospital
• Able to consent

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Exclusion Criteria

• Patients not enrolled in MICRA Study and MICRA CA study at Emory University Hospital and Emory Midtown Hospital
• Children and vulnerable populations

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with MICRA Device	Use of a Tablet	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.
Participants with MICRA Device	Use of a Smart Phone	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Inhibition of Ventricular Pacing While Using a Smart Phone	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.
Number of Participants Experiencing Asynchronous Pacing While Using a Tablet	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.
Device Response While Using a Tablet, Assessed by Ventricular Pacing	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.
Device Response Assessed by Asynchronous Pacing When Using a Smart Phone	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting Clinical Symptoms While Using a Tablet	Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)	Participants were asked to report any clinical symptoms that they experienced when using the tablet.
Number of Participants Reporting Clinical Symptoms While Using a Smart Phone	Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)	Participants were asked to report any clinical symptoms that they experienced when using the smart phone.

Trial Locations

Locations (2)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States