Evaluation of EMI in Patients With Micra Leadless Pacemaker

Electromagnetic Interference Clinical Trial

Official title:

Evaluation of Surgical Electromagnetic Interference in Medtronic Micra Leadless Pacemaker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03508128
• Other study ID #: EdwardH
• Status: Completed
• Start date: April 4, 2018
• Est. completion date: August 18, 2018

Study information

• Verified date: August 2018
• Source: Edward-Elmhurst Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 18, 2018
• Est. primary completion date: August 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

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

Exclusion Criteria:

• no Micra pacemaker

Related Conditions & MeSH terms

• Electromagnetic Interference

Intervention

Other:
• surgical procedure
Surgical procedure

Locations

Country	Name	City	State
United States	EdwardElmhurst Healthcare	Naperville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Edward-Elmhurst Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EMI	Number of subjects with evidence of EMI determined by sensing integrity counter and heart rate histograms	up to 6 months next postop interrogation
Secondary	Device reset	Number of subjects with change in programmed parameters showing device reset VVI 65 5V@.4ms	up to 6 months next postop interrogation