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Use of Defibrillator Information in the Emergency Department

Sponsor
Ohio State University (Other)
Overall Status
Completed
CT.gov ID
NCT00708058
Collaborator
(none)
50
Enrollment
1
Location
31
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study to determine the feasibility of obtaining information stored in existing Medtronic internal defibrillators in patients who present to the Emergency Department(ED) for any reason. In addition, the study will determine if this information is useful to the ED physician in managing the patient's care, specifically as it relates to heart failure.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a prospective observational pilot study to determine if stored data regarding heart function, patient activity level, and other parameters can be used by the ED physician in order to evaluate a patient's cardiac status as it pertains to heart failure. Patients presenting to the ED and who consent have their devices interrogated by research personnel. The data is printed and provided to the treating physician who completes a brief survey about whether the data was useful in managing the patient.All subjects are contacted 30 days after ED or hospital discharge to determine if they have had any ED visits or hospital admissions during that period, and if yes, whether the visits were heart failure related. After all study procedures are performed, a team of 2 cardiologists will review the patient medical record from the study visit, as well as the data obtained from the patient's device in the ED. Each cardiologist, who will be blinded to the other's conclusion, will determine if the patient was having a heart failure exacerbation at the study visit.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Time Perspective:
    Prospective
    Official Title:
    Can Pacemakers, Defibrillators, and Internal Heart Failure Devices Be Used to Evaluate and Guide Management in the Emergency Department?
    Study Start Date :
    Aug 1, 2007
    Actual Primary Completion Date :
    Sep 1, 2008
    Actual Study Completion Date :
    Mar 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. To determine if Medtronic implantable device diagnostics can be used in conjunction with clinical exam to diagnose and guide Emergency Department care [During Emergency Dept. visit]

    2. To determine if there are better methods of making the device diagnostic information accessible to ED physicians/staff [During Emergency Department visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age 18 or older

    • Medtronic IACD present on arrival to Emergency Dept.

    Exclusion Criteria:

    • minors

    • prisoners

    • non-Medtronic AICD

    • unable to provide consent

    • no telephone for 30 day follow up call

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Ohio State University Medical Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University

    Investigators

    • Principal Investigator: Brian C Hiestand, MD, Ohio State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ohio State University
    ClinicalTrials.gov Identifier:
    NCT00708058
    Other Study ID Numbers:
    • 2007H0089
    First Posted:
    Jul 2, 2008
    Last Update Posted:
    Mar 20, 2012
    Last Verified:
    Mar 1, 2012
    Keywords provided by Ohio State University
    Implanted cardiac defibrillators
    Congestive Heart Failure
    Emergency Department
    Additional relevant MeSH terms:
    Heart Failure
    Emergencies

    Study Results

    No Results Posted as of Mar 20, 2012