Evaluation of Cardiac Implanted Electronic Devices (CIED) "Readers" for Hospital Disease Management
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pacemaker Ddd
- Sponsor
- Edward Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Incidence of actionable events after use of readers in suspected TIA/stroke, heart failure and syncope
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Janet Gifford
Nurse Practitioner
Edward Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Incidence of actionable events after use of readers in suspected TIA/stroke, heart failure and syncope
Time Frame: one day
percent of those with events after reader review with actions such as admission/discharge, addition or change in medications, further testing
Secondary Outcomes
- Average number of minutes from transmission to analysis(one day)