NCT03508128

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 5, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

April 5, 2018

Last Update Submit

August 19, 2018

Conditions

Electromagnetic Interference

Outcome Measures

Primary Outcomes (1)

  • EMI

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

    up to 6 months next postop interrogation

Secondary Outcomes (1)

  • Device reset

    up to 6 months next postop interrogation

Study Arms (1)

Micra subjects

Surgical procedure

Other: surgical procedure

Interventions

surgical procedureOTHER

Surgical procedure

Micra subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with Micra leadless pacemakers implanted at Edward-Elmhurst Healthcare since May 2016 who then required a surgical procedure.

You may qualify if:

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

You may not qualify if:

  • no Micra pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EdwardElmhurst Healthcare

Naperville, Illinois, 60174, United States

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Janet Gifford, MSN

    Edward-Elmhurst Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse Practitioner

Study Record Dates

First Submitted

April 5, 2018

First Posted

April 25, 2018

Study Start

April 4, 2018

Primary Completion

August 18, 2018

Study Completion

August 18, 2018

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations

US(1)