Remote Device Interrogation In The Emergency Department
REMEDY
1 other identifier
interventional
99
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2013
CompletedFirst Posted
Study publicly available on registry
June 6, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
December 28, 2016
CompletedFebruary 15, 2019
January 1, 2019
1.6 years
June 4, 2013
June 2, 2016
January 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
On day of Emergency Department admission
Secondary Outcomes (1)
Time to Clinical/Treatment Decision
On day of Emergency Department admission
Other Outcomes (1)
Length of Emergency Department Stay
On day of Emergency Department admission
Study Arms (2)
Interrogation with unpaired remote transmitter
ACTIVE COMPARATORInterrogation with an unpaired remote monitoring transmitter for devices that are compatible.
Interrogation with programmer
NO INTERVENTIONInterrogation with programmer according to usual standard of care
Interventions
Unpaired remote monitoring transmitter
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Genesis Healthcare System
Zanesville, Ohio, 43701, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
23 subjects in the control group and 2 in the study group were not included due to their interrogation not being done in the emergency department.
Results Point of Contact
- Title
- Todd Stirman, Clinical Manager
- Organization
- St Jude Medical, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Girsky, MD
Los Angeles Biomedical Research Institute at Harbor - UCLA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2013
First Posted
June 6, 2013
Study Start
September 1, 2013
Primary Completion
April 1, 2015
Study Completion
July 1, 2015
Last Updated
February 15, 2019
Results First Posted
December 28, 2016
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share