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Remote Interrogation in Rural Emergency Departments (REM RED)

Primary Purpose

Heart Disease, Cardiovascular Disease, Heart Failure

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Unpaired remote monitoring transmitter
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Disease focused on measuring Remote Monitoring, Remote Care, Cardiac Resynchronization Therapy, Pacemaker, Implantable Cardioverter Defibrillator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New Mexico Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Interrogation with unpaired remote monitoring transmitter

Interrogation with Programmer

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time to Clinical Specialist Treatment Decision
ED check in time to time of clinical specialist treatment decision.

Secondary Outcome Measures

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

Full Information

First Posted
April 13, 2015
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02421549
Brief Title
Remote Interrogation in Rural Emergency Departments
Acronym
REM RED
Official Title
Remote Interrogation of Implantable Cardiac Devices in Rural Emergency Departments
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Withdrawn
Study Start Date
December 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac
Keywords
Remote Monitoring, Remote Care, Cardiac Resynchronization Therapy, Pacemaker, Implantable Cardioverter Defibrillator

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interrogation with unpaired remote monitoring transmitter
Arm Type
Active Comparator
Arm Description
Interrogation with unpaired remote monitoring transmitter Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.
Arm Title
Interrogation with Programmer
Arm Type
No Intervention
Arm Description
Interrogation with programmer Interrogation with programmer according to usual standard of care
Intervention Type
Device
Intervention Name(s)
Unpaired remote monitoring transmitter
Other Intervention Name(s)
SJM Merlin@home remote monitoring transmitter
Primary Outcome Measure Information:
Title
Time to Clinical Specialist Treatment Decision
Description
ED check in time to time of clinical specialist treatment decision.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Health Care Utilization Rate
Description
Device related hospitalizations, ED visits and unscheduled office visits/urgent care visits within 30 days of the initial ED visit.
Time Frame
Within 30 days of initial ED visit
Other Pre-specified Outcome Measures:
Title
Time to Device Interrogation
Description
ED check in time until time of device interrogation
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presents to Emergency Department with an implanted pacemaker or defibrillator. Are 18 years of age or older. Are willing and able to provide informed consent for study participation. Are willing and able to complete a 30-60 day follow up phone call. Exclusion Criteria: 1. Are unwilling to provide written informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross Downey, MD
Organizational Affiliation
New Mexico Heart Institute, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Mexico Heart Institute
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States

12. IPD Sharing Statement

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Remote Interrogation in Rural Emergency Departments

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