Evaluation of CIED "Readers" for Disease Management

Completed

Conditions studied: Pacemaker Ddd, ICD

In brief

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.

Key facts

Study ID

NCT03338946

Run by

Edward Hospital

People needed

100

Starts

2018-04-05

Expected to finish

2019-07-16

Last updated by the study team

2019-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Edward Hospital — Naperville, Illinois, United States

Full record on ClinicalTrials.gov

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