Evaluation of EMI in Patients With Micra Leadless Pacemaker

NCT ID: NCT03508128

Last Updated: 2018-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-04

Study Completion Date

2018-08-18

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Electromagnetic Interference

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Micra subjects

Surgical procedure

surgical procedure

Intervention Type OTHER

Surgical procedure

Interventions

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surgical procedure

Surgical procedure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* no Micra pacemaker
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edward-Elmhurst Health System

OTHER

Sponsor Role lead

Responsible Party

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Janet Gifford

Nurse Practitioner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Janet Gifford, MSN

Role: PRINCIPAL_INVESTIGATOR

Edward-Elmhurst Health

Locations

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EdwardElmhurst Healthcare

Naperville, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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EdwardH

Identifier Type: -

Identifier Source: org_study_id

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