Evaluation of EMI in Patients With Micra Leadless Pacemaker | NCT03508128

Studies
Evaluation of EMI in Patients With Micra Leadless Pacemaker

NCT03508128

Sponsor

Edward-Elmhurst Health System

Status

Completed

Last Update Posted

Aug 21, 2018Actual

Enrollment

7Actual

Phase

Not provided

Conditions

Electromagnetic Interference

Interventions

surgical procedure

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 4, 2018Actual

Primary Completion Date

Aug 18, 2018Actual

Completion Date

Aug 18, 2018Actual

First Submitted Date

Apr 5, 2018

First Submission Date that Met QC Criteria

Apr 16, 2018

First Posted Date

Apr 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2018

Last Update Posted Date

Aug 21, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Micra subjects		Surgical procedure	Other: surgical procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgical procedure	Other	Surgical procedure	Micra subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Device reset	Number of subjects with change in programmed parameters showing device reset VVI 65 5V@.4ms	up to 6 months next postop interrogation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

subjects with an implanted Micra pacemaker who required a surgical procedure

Exclusion Criteria:

no Micra pacemaker

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janet Gifford, MSN	Edward-Elmhurst Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
EdwardElmhurst Healthcare		Naperville	Illinois	60174	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided