Back to resultsRemote Device Interrogation In The Emergency Department (REMEDY)
Primary Purpose
Heart Disease, Cardiovascular Disease, Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unpaired remote monitoring transmitter
Sponsored by
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
Inclusion Criteria:
- Present to Emergency Department with an implanted pacemaker or defibrillator.
- Are 18 years of age or older, or of legal age to give informed consent specific to state law.
- Are willing and able to provide informed consent for study participation.
Exclusion Criteria:
- None
Sites / Locations
- Genesis Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Interrogation with unpaired remote transmitter
Interrogation with programmer
Arm Description
Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.
Interrogation with programmer according to usual standard of care
Outcomes
Primary Outcome Measures
Time to Interrogation
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.
Secondary Outcome Measures
Time to Clinical/Treatment Decision
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01871090
Brief Title
Remote Device Interrogation In The Emergency Department
Acronym
REMEDY
Official Title
Remote Device Interrogation In The Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
July 2015 (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 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.
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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interrogation with unpaired remote transmitter
Arm Type
Active Comparator
Arm Description
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 according to usual standard of care
Intervention Type
Device
Intervention Name(s)
Unpaired remote monitoring transmitter
Other Intervention Name(s)
St. Jude Medical Merlin@home remote monitoring transmitter
Intervention Description
Unpaired remote monitoring transmitter
Primary Outcome Measure Information:
Title
Time to Interrogation
Description
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.
Time Frame
On day of Emergency Department admission
Secondary Outcome Measure Information:
Title
Time to Clinical/Treatment Decision
Description
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).
Time Frame
On day of Emergency Department admission
Other Pre-specified Outcome Measures:
Title
Length of Emergency Department Stay
Description
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).
Time Frame
On day of Emergency Department admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Present to Emergency Department with an implanted pacemaker or defibrillator.
Are 18 years of age or older, or of legal age to give informed consent specific to state law.
Are willing and able to provide informed consent for study participation.
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Girsky, MD
Organizational Affiliation
Los Angeles Biomedical Research Institute at Harbor - UCLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genesis Healthcare System
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Remote Device Interrogation In The Emergency Department
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