Evaluation of EMI in Patients With Micra Leadless Pacemaker
- Conditions
- Electromagnetic Interference
- Registration Number
- NCT03508128
- Lead Sponsor
- Edward-Elmhurst Health System
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Not provided
- no Micra pacemaker
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method EMI up to 6 months next postop interrogation Number of subjects with evidence of EMI determined by sensing integrity counter and heart rate histograms
- Secondary Outcome Measures
Name Time Method Device reset up to 6 months next postop interrogation Number of subjects with change in programmed parameters showing device reset VVI 65 5V@.4ms
Trial Locations
- Locations (1)
EdwardElmhurst Healthcare
🇺🇸Naperville, Illinois, United States
EdwardElmhurst Healthcare🇺🇸Naperville, Illinois, United States