NCT03508128

Evaluation of EMI in Patients With Micra Leadless Pacemaker

Evaluation of Surgical Electromagnetic Interference in Medtronic Micra Leadless Pacemaker

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Edward-Elmhurst Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Electromagnetic Interference

Interventions

Type	Name	Description
OTHER	surgical procedure	Surgical procedure

Timeline

• Start date: 2018-04-04
• Primary completion: 2018-08-18
• Completion: 2018-08-18
• First posted: 2018-04-25
• Last updated: 2018-08-21

Locations

1 site across 1 country: United States