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Remote Interrogation in Rural Emergency Departments (REM RED)

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ClinicalTrials.gov Identifier: NCT02421549
Recruitment Status : Withdrawn
First Posted : April 20, 2015
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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
Heart Disease Cardiovascular Disease Heart Failure Arrhythmias, Cardiac Device: Unpaired remote monitoring transmitter Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : December 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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 Name: SJM Merlin@home remote monitoring transmitter

No Intervention: Interrogation with Programmer
Interrogation with programmer Interrogation with programmer according to usual standard of care



Primary Outcome Measures :
  1. Time to Clinical Specialist Treatment Decision [ Time Frame: 1 day ]
    ED check in time to time of clinical specialist treatment decision.


Secondary Outcome Measures :
  1. Health Care Utilization Rate [ Time Frame: 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 [ Time Frame: 1 day ]
    ED check in time until time of device interrogation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421549


Locations
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United States, New Mexico
New Mexico Heart Institute
Albuquerque, New Mexico, United States, 87102
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Ross Downey, MD New Mexico Heart Institute, PA

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02421549     History of Changes
Other Study ID Numbers: 60054491
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Keywords provided by Abbott Medical Devices:
Remote Monitoring
Remote Care
Cardiac Resynchronization Therapy
Pacemaker
Implantable Cardioverter Defibrillator
Additional relevant MeSH terms:
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Heart Diseases
Arrhythmias, Cardiac
Emergencies
Cardiovascular Diseases
Disease Attributes
Pathologic Processes