Evaluation of CIED "Readers" for Disease Management

ICD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338946
• Other study ID #: Edward Hospital
• Status: Completed
• Start date: April 5, 2018
• Est. completion date: July 16, 2019

Study information

• Verified date: July 2019
• Source: Edward-Elmhurst Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 16, 2019
• Est. primary completion date: July 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ICD
• Pacemaker Ddd

Intervention

Device:
• CIED interrogation
CareLink Express interrogation

Locations

Country	Name	City	State
United States	Edward Hospital	Naperville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Edward Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of non-EP trained staff rating CIED readers as very easy or easy	Likert scale to staff on ease of use	one year
Primary	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	Average number of minutes from transmission to analysis	number of minutes from CareLink Express interrogation to analysis	one day