Evaluation of EMI in Patients With Micra Leadless Pacemaker

Edward-Elmhurst Health System

Status: Completed

Conditions: Electromagnetic Interference

Treatments: Other: surgical procedure

Study type: Observational

Funder types: Other

Identifiers

NCT03508128

EdwardH

Details and patient eligibility

About

Subjects with Medtronic Micra leadless pacemaker who require surgical procedures will have postoperative interrogations reviewed for evidence of electromagnetic interference (EMI).

Full description

Patients with pacemakers have a potential risk of EMI from sources including electrosurgery which can cause oversensing, pacing inhibition and device reset. There is limited data on surgical EMI in Medtronic Micra leadless pacemakers. The goal of this study is to evaluate for surgical EMI in subjects with leadless pacemakers.

Subjects with Micra leadless pacemakers requiring surgery will have procedure records reviewed for type of procedure and use of electrosurgery. Next postoperative device interrogation will be reviewed for evidence of EMI. EMI will be evaluated by review of sensing integrity counter, heart rate histograms and device reset.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects with an implanted Micra pacemaker who required a surgical procedure

Exclusion criteria

• no Micra pacemaker

Trial design

7 participants in 1 patient group

Micra subjects

Description:

Surgical procedure

Treatment:

Other: surgical procedure