Remote Interrogation in Rural Emergency Departments (REM RED)

January 31, 2019 updated by: Abbott Medical Devices

Remote Interrogation of Implantable Cardiac Devices in Rural Emergency Departments

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • New Mexico Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Clinical Specialist Treatment Decision
Time Frame: 1 day
ED check in time to time of clinical specialist treatment decision.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 30 days of initial ED visit

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Device Interrogation
Time Frame: 1 day
ED check in time until time of device interrogation
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (Estimate)

April 20, 2015

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 60054491

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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