N/A
Completed N=20
Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)
Bradycardia, Atrial Tachyarrhythmia
Source: ClinicalTrials.gov NCT02758210 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Device Response Assessed by Asynchronous Pacing When Using a Smart Phone — 528; 547 ohms
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Response Assessed by Asynchronous Pacing When Using a Smart Phone |
528; 547 | — |
| PRIMARY Number of Participants Experiencing Asynchronous Pacing While Using a Tablet |
0; 0 | — |
| PRIMARY Number of Participants Experiencing Inhibition of Ventricular Pacing While Using a Smart Phone |
— | — |
| PRIMARY Device Response While Using a Tablet, Assessed by Ventricular Pacing |
10.8; 11 | — |
| SECONDARY Number of Participants Reporting Clinical Symptoms While Using a Smart Phone |
— | — |
| SECONDARY Number of Participants Reporting Clinical Symptoms While Using a 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
Data sourced from ClinicalTrials.gov (NCT02758210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.