ICD, Pacemaker Ddd
Conditions
Keywords
Remote monitoring
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.
Interventions
DEVICECIED interrogation
CareLink Express interrogation
Sponsors
Edward Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Average number of minutes from transmission to analysis | one day | number of minutes from CareLink Express interrogation to analysis |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of non-EP trained staff rating CIED readers as very easy or easy | one year | Likert scale to staff on ease of use |
Countries
United States
Outcome results
None listed