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Completed

NCT Number: NCT03508128

Evaluation of EMI in Patients With Micra Leadless Pacemaker

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

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Key information

Conditions

Electromagnetic Interference

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

EdwardElmhurst Healthcare

Naperville, Illinois, 60174, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • no Micra pacemaker

Treatment and study plan

surgical procedure

Other

Surgical procedure

Primary outcomes

  1. EMI

    Time frame: up to 6 months next postop interrogation

    Number of subjects with evidence of EMI determined by sensing integrity counter and heart rate histograms

Secondary outcomes

  1. Device reset

    Time frame: up to 6 months next postop interrogation

    Number of subjects with change in programmed parameters showing device reset VVI 65 [email protected]

Sponsors and collaborators

Lead sponsor

Edward-Elmhurst Health System

Other

Registry information

Official study title

Evaluation of Surgical Electromagnetic Interference in Medtronic Micra Leadless Pacemaker

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 25, 2018
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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