Bradycardia, Atrial Tachyarrhythmia
Conditions
Keywords
Bradycardia, Atrial Tachyarrhythmia, Smart Phone, Tablet
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.
Interventions
DEVICEUse 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).
DEVICEUse 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).
Sponsors
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from those already participating in the MICRA Study and MICRA CA Study at Emory University Hospital and Emory University Hospital Midtown. Participants for this substudy were enrolled between April 2016 and October 2016.
Participants by arm
| Arm | Count |
|---|---|
| Participants With MICRA Device Participants that received the MICRA device prior to study enrollment and who consented to having monitored use of a smart phone and a tablet at a single study visit. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Participants With MICRA Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 78.9 years STANDARD_DEVIATION 9.4 |
| Atrioventricular (AV) node ablation concomitantly with the MICRA procedure | 5 Participants |
| Congestive heart failure | 6 Participants |
| Diabetes | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hypertension | 17 Participants |
| Pacing indication: permanent atrial fibrillation and high-grade AV block | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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.
Time frame: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With MICRA Device | Device Response Assessed by Asynchronous Pacing When Using a Smart Phone | Before Smart Phone Use | 528 ohms | Standard Deviation 88 |
| Participants With MICRA Device | Device Response Assessed by Asynchronous Pacing When Using a Smart Phone | During Smart Phone Use | 547 ohms | Standard Deviation 87 |
Primary
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.
Time frame: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With MICRA Device | Device Response While Using a Tablet, Assessed by Ventricular Pacing | Sensing Amplitude Before Tablet Use | 10.8 millivolts (mV) | Standard Deviation 4.7 |
| Participants With MICRA Device | Device Response While Using a Tablet, Assessed by Ventricular Pacing | Sensing Amplitude During Tablet Use | 11 millivolts (mV) | Standard Deviation 4.8 |
Primary
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.
Time frame: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With MICRA Device | Number of Participants Experiencing Asynchronous Pacing While Using a Tablet | Asynchronous Pacing Before Tablet Use | 0 Participants |
| Participants With MICRA Device | Number of Participants Experiencing Asynchronous Pacing While Using a Tablet | Asynchronous Pacing During Tablet Use | 0 Participants |
Primary
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.
Time frame: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With MICRA Device | Number of Participants Experiencing Inhibition of Ventricular Pacing While Using a Smart Phone | 0 Participants |
Secondary
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.
Time frame: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With MICRA Device | Number of Participants Reporting Clinical Symptoms While Using a Smart Phone | 0 Participants |
Secondary
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.
Time frame: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With MICRA Device | Number of Participants Reporting Clinical Symptoms While Using a Tablet | 0 Participants |