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Evaluation of CIED "Readers" for Disease Management

Sponsor
Edward Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03338946
Collaborator
(none)
100
Enrollment
1
Location
15.3
Actual Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the use of remote interrogation (readers) of CIEDs in evaluation of suspected TIA/stroke patients, HF or those experiencing syncope. This approach has the potential to advance the practice of CIED evaluation by staff without specialized training in cardiac electrophysiology (non-EP staff). We hypothesize that actionable events will be identified with use of CIED readers. These events may include identification of atrial fibrillation in TIA/stroke patients, percentage biventricular pacing in patients with HF or evaluation of arrhythmic events in syncope patients. We believe that non-EP staff will find CIED readers easy or very easy to use and that time from transmission to analysis for non-EP trained staff will be low.

Condition or Disease Intervention/Treatment Phase
  • Device: CIED interrogation

Detailed Description

Subjects with CIEDs undergoing evaluation for TIA/stroke, HF or syncope will be reviewed for inclusion/exclusion criteria. CIED interrogation, demographics and time of interrogation will be collected. Review of interrogation and medical record will be done to evaluate for actionable events including CIED programming, initiation or change in medications, admission/discharge or decision for further testing.

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Cardiac Implanted Electronic Devices (CIED) "Readers" for Hospital Disease Management
Actual Study Start Date :
Apr 5, 2018
Actual Primary Completion Date :
Jul 16, 2019
Actual Study Completion Date :
Jul 16, 2019

Arms and Interventions

Arm Intervention/Treatment
CIED subjects

CIED interrogation

Device: CIED interrogation
CareLink Express interrogation
Other Names:
  • Remote monitoring

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of actionable events after use of readers in suspected TIA/stroke, heart failure and syncope [one day]

      percent of those with events after reader review with actions such as admission/discharge, addition or change in medications, further testing

    Secondary Outcome Measures

    1. Average number of minutes from transmission to analysis [one day]

      number of minutes from CareLink Express interrogation to analysis

    Other Outcome Measures

    1. Incidence of non-EP trained staff rating CIED readers as very easy or easy [one year]

      Likert scale to staff on ease of use

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • have a Medtronic CIED compatible with Medtronic CareLink Express

    • being evaluated for heart failure, TIA/stroke or syncope

    • able to read and speak English

    Exclusion Criteria:

    -CIED from other than Medtronic

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Edward Hospital Naperville Illinois United States 60174

    Sponsors and Collaborators

    • Edward Hospital

    Investigators

    • Principal Investigator: Janet Gifford, MSN, Edward Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janet Gifford, Nurse Practitioner, Edward Hospital
    ClinicalTrials.gov Identifier:
    NCT03338946
    Other Study ID Numbers:
    • Edward Hospital
    First Posted:
    Nov 9, 2017
    Last Update Posted:
    Jul 18, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Janet Gifford, Nurse Practitioner, Edward Hospital
    Remote monitoring

    Study Results

    No Results Posted as of Jul 18, 2019