Remote Device Interrogation In The Emergency Department (REMEDY)

January 31, 2019 updated by: Abbott Medical Devices

A prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with St. Jude Medical remote care compatible devices interrogated by the unpaired Merlin@home transmitter in the Emergency Department (ED). Two sites will enroll up to 100 patients total.

Expected duration of the study is 6 months. Once enrolled the patient will participate in the study for the duration of the Emergency Department stay, until discharged or admitted to the hospital.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

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
    • Ohio
      • Zanesville, Ohio, United States, 43701
        • Genesis HealthCare System

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. Present to Emergency Department with an implanted pacemaker or defibrillator.
  2. Are 18 years of age or older, or of legal age to give informed consent specific to state law.
  3. Are willing and able to provide informed consent for study participation.

Exclusion Criteria:

  • None

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 transmitter
Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.
Device: Unpaired remote monitoring transmitter
Unpaired remote monitoring transmitter
Other Names:
  • St. Jude Medical Merlin@home remote monitoring transmitter
No Intervention: 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 Interrogation
Time Frame: On day of Emergency Department admission
Time to interrogation is defined as the time from Triage (decision to interrogate the device) until the first of: Completion of interrogation, Time of Clinical/Treatment decision, or Emergency Department check out time.
On day of Emergency Department admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Clinical/Treatment Decision
Time Frame: On day of Emergency Department admission
Defined as the time from the Emergency Department Check In Time until the first of: Time of Clinical/Treatment Decision or Emergency Department Check Out Time (discharged/leaves Emergency Department or admitted to hospital).
On day of Emergency Department admission

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Emergency Department Stay
Time Frame: On day of Emergency Department admission
Defined as the time from the Emergency Department Check In Time until the Emergency Department Check Out Time (discharged/leaves Emergency Department or admitted to hospital).
On day of Emergency Department admission

Collaborators and Investigators

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

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Marc Girsky, MD, Los Angeles Biomedical Research Institute at Harbor - UCLA

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

September 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Actual)

February 15, 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

  • 60047158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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