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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with MICRA Device | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes) |
| 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. | Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes) |
| 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. | Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes) |
| 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. | Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes) |
| Number of Participants Reporting Clinical Symptoms While Using a Tablet |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mikhael El Chami, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States | ||
| Emory University Hospital |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients who were eligible to participate and were randomized to a study arm
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | ohms | Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes) |
|
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Participants reported any adverse events from the time of consenting to take part in the study throughout the duration of the study activities. All study activities were performed in a single study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mikhael El Chami, MD | Emory University | 404-686-2504 | melcham@emory.edu |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| 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). |
|
Participants were asked to report any clinical symptoms that they experienced when using the tablet. |
| Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Hypertension | Participants with a diagnosis of hypertension | Count of Participants | Participants |
|
| Diabetes | Participants with a diagnosis of diabetes | Count of Participants | Participants |
|
| Congestive heart failure | Participants with a diagnosis of congestive heart failure | Count of Participants | Participants |
|
| Pacing indication: permanent atrial fibrillation and high-grade AV block | Count of Participants | Participants |
|
| Atrioventricular (AV) node ablation concomitantly with the MICRA procedure | Count of Participants | Participants |
|
| Participants |
|
|
| 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. | Posted | Count of Participants | Participants | Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes) |
|
|
|
| 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. | Posted | Count of Participants | Participants | Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes) |
|
|
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| 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. | Posted | Mean | Standard Deviation | millivolts (mV) | Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes) |
|
|
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| 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. | Posted | Count of Participants | Participants | Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes) |
|
|
|
| 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. | Posted | Count of Participants | Participants | Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes) |
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| 0 |
| 20 |
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| 20 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |