NCT03338946

Evaluation of CIED "Readers" for Disease Management

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Edward Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pacemaker Ddd
• ICD

Interventions

Type	Name	Description
DEVICE	CIED interrogation	CareLink Express interrogation

Timeline

• Start date: 2018-04-05
• Primary completion: 2019-07-16
• Completion: 2019-07-16
• First posted: 2017-11-09
• Last updated: 2019-07-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study