Clinical trial NCT02758210: Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)
Official title: Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia, Atrial Tachyarrhythmia
Keywords: Bradycardia
Atrial Tachyarrhythmia
Smart Phone
Tablet
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Device Response Assessed by Asynchronous Pacing When Using a Smart Phone
timeFrame: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
measure: Number of Participants Experiencing Asynchronous Pacing While Using a Tablet
timeFrame: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
measure: Number of Participants Experiencing Inhibition of Ventricular Pacing While Using a Smart Phone
timeFrame: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
measure: Device Response While Using a Tablet, Assessed by Ventricular Pacing
timeFrame: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Secondary outcomes:
measure: Number of Participants Reporting Clinical Symptoms While Using a Smart Phone
timeFrame: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
measure: Number of Participants Reporting Clinical Symptoms While Using a Tablet
timeFrame: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Mikhael El Chami, MD
role: PRINCIPAL_INVESTIGATOR
References: