Evaluation of CIED "Readers" for Disease Management

NCT03338946 | Completed FDA Device

• 1 other identifier: Edward Hospital
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pacemaker Ddd; ICD

Keywords

Remote monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Average number of minutes from transmission to analysis

  one day

Other Outcomes (1)

• Incidence of non-EP trained staff rating CIED readers as very easy or easy

  one year

Study Arms (1)

CIED subjects

CIED interrogation

Device: CIED interrogation

Interventions

CIED interrogation DEVICE

CareLink Express interrogation

Also known as: Remote monitoring

CIED subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• have a Medtronic CIED compatible with Medtronic CareLink Express
• being evaluated for heart failure, TIA/stroke or syncope
• able to read and speak English

You may not qualify if:

• CIED from other than Medtronic

Sponsors & Collaborators

• Edward Hospital: lead

Study Sites (1)

Edward Hospital

Naperville, Illinois, 60174, United States

Location

Study Officials

• Janet Gifford, MSN

  Edward Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Practitioner

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 9, 2017
• Study Start: April 5, 2018
• Primary Completion: July 16, 2019
• Study Completion: July 16, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

US (1)