Evaluation of CIED "Readers" for Disease Management

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

Study Overview

• Status: Completed
• Conditions: ICD; Pacemaker Ddd
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Naperville, Illinois, United States, 60174
      • Edward Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CIED subjects; CIED interrogation	Device: CIED interrogation; CareLink Express interrogation; Other Names: Remote monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of actionable events after use of readers in suspected TIA/stroke, heart failure and syncope	percent of those with events after reader review with actions such as admission/discharge, addition or change in medications, further testing	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average number of minutes from transmission to analysis	number of minutes from CareLink Express interrogation to analysis	one day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of non-EP trained staff rating CIED readers as very easy or easy	Likert scale to staff on ease of use	one year

Collaborators and Investigators

• Sponsor: Edward Hospital
• Investigators: Principal Investigator: Janet Gifford, MSN, Edward Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2018
• Primary Completion (Actual): July 16, 2019
• Study Completion (Actual): July 16, 2019

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Remote monitoring
• Other Study ID Numbers: Edward Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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