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Evaluation of CIED "Readers" for Disease Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338946
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Janet Gifford, Edward Hospital

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
Pacemaker Ddd ICD 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.

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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 : April 5, 2018
Actual Primary Completion Date : July 16, 2019
Actual Study Completion Date : July 16, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CIED subjects
CIED interrogation
Device: CIED interrogation
CareLink Express interrogation
Other Name: Remote monitoring




Primary Outcome Measures :
  1. Incidence of actionable events after use of readers in suspected TIA/stroke, heart failure and syncope [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: one year ]
    Likert scale to staff on ease of use



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects being seen in Edward ED, HF clinic or inpatient units being evaluated for HF, TIA/stroke or syncope
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338946


Locations
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United States, Illinois
Edward Hospital
Naperville, Illinois, United States, 60174
Sponsors and Collaborators
Edward Hospital
Investigators
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Principal Investigator: Janet Gifford, MSN Edward Hospital
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Responsible Party: Janet Gifford, Nurse Practitioner, Edward Hospital
ClinicalTrials.gov Identifier: NCT03338946    
Other Study ID Numbers: Edward Hospital
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, Edward Hospital:
Remote monitoring