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Evaluation of CIED "Readers" for Disease Management

E

Edward Hospital

Status

Completed

Conditions

Pacemaker Ddd
ICD

Treatments

Device: CIED interrogation

Study type

Observational

Funder types

Other

Identifiers

NCT03338946
Edward Hospital

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

CIED subjects
Description:
CIED interrogation
Treatment:
Device: CIED interrogation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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