Trial Outcomes & Findings for Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA) (NCT NCT02758210)
NCT ID: NCT02758210
Last Updated: 2017-11-09
Results Overview
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.
COMPLETED
NA
20 participants
Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
2017-11-09
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)
Baseline characteristics by cohort
| Measure |
Participants With MICRA Device
n=20 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
|
Age, Continuous
|
78.9 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
|
Hypertension
|
17 Participants
n=5 Participants
|
|
Diabetes
|
8 Participants
n=5 Participants
|
|
Congestive heart failure
|
6 Participants
n=5 Participants
|
|
Pacing indication: permanent atrial fibrillation and high-grade AV block
|
10 Participants
n=5 Participants
|
|
Atrioventricular (AV) node ablation concomitantly with the MICRA procedure
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With MICRA Device
n=20 Participants
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.
|
|---|---|
|
Device Response Assessed by Asynchronous Pacing When Using a Smart Phone
Before Smart Phone Use
|
528 ohms
Standard Deviation 88
|
|
Device Response Assessed by Asynchronous Pacing When Using a Smart Phone
During Smart Phone Use
|
547 ohms
Standard Deviation 87
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With MICRA Device
n=20 Participants
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.
|
|---|---|
|
Number of Participants Experiencing Asynchronous Pacing While Using a Tablet
Asynchronous Pacing Before Tablet Use
|
0 Participants
|
|
Number of Participants Experiencing Asynchronous Pacing While Using a Tablet
Asynchronous Pacing During Tablet Use
|
0 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With MICRA Device
n=20 Participants
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.
|
|---|---|
|
Number of Participants Experiencing Inhibition of Ventricular Pacing While Using a Smart Phone
|
0 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With MICRA Device
n=20 Participants
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.
|
|---|---|
|
Device Response While Using a Tablet, Assessed by Ventricular Pacing
Sensing Amplitude Before Tablet Use
|
10.8 millivolts (mV)
Standard Deviation 4.7
|
|
Device Response While Using a Tablet, Assessed by Ventricular Pacing
Sensing Amplitude During Tablet Use
|
11 millivolts (mV)
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With MICRA Device
n=20 Participants
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.
|
|---|---|
|
Number of Participants Reporting Clinical Symptoms While Using a Smart Phone
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants With MICRA Device
n=20 Participants
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.
|
|---|---|
|
Number of Participants Reporting Clinical Symptoms While Using a Tablet
|
0 Participants
|
Adverse Events
Participants With MICRA Device
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place