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Evaluation of CIED "Readers" for Disease Management

NCT03338946 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-07-18

No results posted yet for this study

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.

Conditions

  • Pacemaker Ddd
  • ICD

Interventions

DEVICE

CIED interrogation

CareLink Express interrogation

Sponsors & Collaborators

  • Edward Hospital

    lead OTHER

Principal Investigators

  • Janet Gifford, MSN · Edward Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2019-07-16
Completion
2019-07-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03338946 on ClinicalTrials.gov