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Completed

NCT Number: NCT03338946

Evaluation of CIED "Readers" for Disease Management

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.

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Key information

Conditions

Pacemaker Ddd ICD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Edward Hospital

Naperville, Illinois, 60174, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CIED interrogation

Device

CareLink Express interrogation

Other names: Remote monitoring

Primary outcomes

  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 outcomes

  1. Average number of minutes from transmission to analysis

    Time frame: one day

    number of minutes from CareLink Express interrogation to analysis

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Edward Hospital

Other

Registry information

Official study title

Evaluation of Cardiac Implanted Electronic Devices (CIED) "Readers" for Hospital Disease Management

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2017
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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