Back to resultsEvaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA) (MICRA)
Primary Purpose
Bradycardia, Atrial Tachyarrhythmia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of a Tablet
Use of a Smart Phone
Sponsored by
About this trial
This is an interventional other trial for Bradycardia, Atrial Tachyarrhythmia focused on measuring Bradycardia, Atrial Tachyarrhythmia, Smart Phone, Tablet
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
Sites / Locations
- Emory University Hospital Midtown
- Emory University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants with MICRA Device
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02758210
Brief Title
Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)
Acronym
MICRA
Official Title
Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
October 24, 2016 (Actual)
Study Completion Date
October 24, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Atrial Tachyarrhythmia
Keywords
Bradycardia, Atrial Tachyarrhythmia, Smart Phone, Tablet
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants with MICRA Device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Use of a Tablet
Intervention Description
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
Intervention Name(s)
Use of a Smart Phone
Intervention Description
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 Outcome Measure Information:
Title
Device Response Assessed by Asynchronous Pacing When Using a Smart Phone
Description
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.
Time Frame
Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Title
Number of Participants Experiencing Asynchronous Pacing While Using a Tablet
Description
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.
Time Frame
Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Title
Number of Participants Experiencing Inhibition of Ventricular Pacing While Using a Smart Phone
Description
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.
Time Frame
Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Title
Device Response While Using a Tablet, Assessed by Ventricular Pacing
Description
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.
Time Frame
Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Secondary Outcome Measure Information:
Title
Number of Participants Reporting Clinical Symptoms While Using a Smart Phone
Description
Participants were asked to report any clinical symptoms that they experienced when using the smart phone.
Time Frame
Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Title
Number of Participants Reporting Clinical Symptoms While Using a Tablet
Description
Participants were asked to report any clinical symptoms that they experienced when using the tablet.
Time Frame
Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikhael El Chami, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)
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