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

NCT ID: NCT02758210

Last Updated: 2017-11-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-10-24

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.

Conditions

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Bradycardia, Atrial Tachyarrhythmia

Keywords

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Bradycardia Atrial Tachyarrhythmia Smart Phone Tablet

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Use of a Tablet

Intervention Type 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

Intervention Type 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).

Interventions

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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).

Intervention Type 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).

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Mikhael El Chami

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mikhael El Chami, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00084576

Identifier Type: -

Identifier Source: org_study_id