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REM RED: Remote Interrogation in Rural Emergency Departments

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02421549
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
13
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A retrospective, multi-center, proof-of-concept study to evaluate the use of remote monitoring in rural emergency departments to decrease time to treatment decision for pacemaker and defibrillator patients using the St Jude Medical Merlin@home transmitter. The purpose of the study is to determine if utilization of remote monitoring technology in a rural emergency department may improve patient care.

Up to 10 rural ED sites will enroll a total of 200 patients. One hundred patients will be in the remote monitoring group comprised of patients with SJM devices compatible with the unpaired transmitter and 100 patients will be in the usual medical care group comprised of patients with SJM devices that are not compatible with the unpaired transmitter or that have a competitor's device.

Condition or Disease Intervention/Treatment Phase
  • Device: Unpaired remote monitoring transmitter
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Remote Interrogation of Implantable Cardiac Devices in Rural Emergency Departments
Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Interrogation with unpaired remote monitoring transmitter

Interrogation with unpaired remote monitoring transmitter Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.

Device: Unpaired remote monitoring transmitter
Other Names:
  • SJM Merlin@home remote monitoring transmitter

    		•
    No Intervention: Interrogation with Programmer

    Interrogation with programmer Interrogation with programmer according to usual standard of care

    Outcome Measures

    Primary Outcome Measures

    1. Time to Clinical Specialist Treatment Decision [1 day]

      ED check in time to time of clinical specialist treatment decision.

    Secondary Outcome Measures

    1. Health Care Utilization Rate [Within 30 days of initial ED visit]

      Device related hospitalizations, ED visits and unscheduled office visits/urgent care visits within 30 days of the initial ED visit.

    Other Outcome Measures

    1. Time to Device Interrogation [1 day]

      ED check in time until time of device interrogation

    Eligibility Criteria

    Criteria

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

    1. Presents to Emergency Department with an implanted pacemaker or defibrillator.

    2. Are 18 years of age or older.

    3. Are willing and able to provide informed consent for study participation.

    4. Are willing and able to complete a 30-60 day follow up phone call.

    Exclusion Criteria:
    1. Are unwilling to provide written informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New Mexico Heart Institute Albuquerque New Mexico United States 87102

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

    • Principal Investigator: Ross Downey, MD, New Mexico Heart Institute, PA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT02421549
    Other Study ID Numbers:
    • 60054491
    First Posted:
    Apr 20, 2015
    Last Update Posted:
    Feb 4, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Abbott Medical Devices
    Remote Monitoring
    Remote Care
    Cardiac Resynchronization Therapy
    Pacemaker
    Implantable Cardioverter Defibrillator
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Heart Diseases
    Arrhythmias, Cardiac
    Emergencies

    Study Results

    No Results Posted as of Feb 4, 2019