Evaluation of CIED "Readers" for Disease Management

Completed

• Conditions: Pacemaker Ddd; ICD
• Interventions: Device: CIED interrogation

• Registration Number: NCT03338946
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-09
• Study Start: 2018-04-05
• Status Verified: 2019-07
• Primary Completion: 2019-07-16
• Study Completion: 2019-07-16
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CIED subjects	CIED interrogation	CIED interrogation

Primary Outcome Measures

Name	Time	Method
Incidence of actionable events after use of readers in suspected TIA/stroke, heart failure and syncope	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

Name	Time	Method
Average number of minutes from transmission to analysis	one day	number of minutes from CareLink Express interrogation to analysis

Trial Locations

Locations (1)

Edward Hospital; 🇺🇸 Naperville, Illinois, United States