Evaluation of Surgical Electromagnetic Interference in Medtronic Micra Leadless Pacemaker
| Registry | NCT03508128 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 7 (Actual) |
| Sponsor | Edward-Elmhurst Health System (Other) |
| Conditions | Electromagnetic Interference |
| Interventions | surgical procedure (Other) |
| Dates | start 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 in United States |
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Subjects with Medtronic Micra leadless pacemaker who require surgical procedures will have postoperative interrogations reviewed for evidence of electromagnetic interference (EMI).
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Micra subjects | Other: surgical procedure | Surgical procedure |
Sex: All, ages: 18 Years to any
Inclusion criteria: * subjects with an implanted Micra pacemaker who required a surgical procedure Exclusion Criteria: * no Micra pacemaker
| Facility | City | Country | Status |
|---|---|---|---|
| EdwardElmhurst Healthcare | Naperville, Illinois | United States |