N/A N=20 Other

Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)

Bradycardia, Atrial Tachyarrhythmia

Bottom Line

View on ClinicalTrials.gov: NCT02758210 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2017

Primary outcome: Primary: Device Response Assessed by Asynchronous Pacing When Using a Smart Phone — 528; 547 ohms

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Use of a Tablet (Device); Use of a Smart Phone (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Oct 2016

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	—	—

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).

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

View full record on ClinicalTrials.gov →

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.