Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-01 @ 2:29 AM
Study NCT ID:
NCT03508128
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2018-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of EMI in Patients With Micra Leadless Pacemaker
Sponsor:
Edward-Elmhurst Health System
Organization:
Study Overview
Official Title:
Evaluation of Surgical Electromagnetic Interference in Medtronic Micra Leadless Pacemaker
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: