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Completed

NCT Number: NCT02758210

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

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Key information

Conditions

Bradycardia, Atrial Tachyarrhythmia Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of a Tablet

Device

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 Phone

Device

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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)

    Participants were asked to report any clinical symptoms that they experienced when using the smart phone.

  2. 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)

    Participants were asked to report any clinical symptoms that they experienced when using the tablet.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Acronym: MICRA

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 2, 2016
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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