Remote Interrogation in Rural Emergency Departments (REM RED)
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|ClinicalTrials.gov Identifier: NCT02421549|
Recruitment Status : Withdrawn
First Posted : April 20, 2015
Last Update Posted : February 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Disease Cardiovascular Disease Heart Failure Arrhythmias, Cardiac||Device: Unpaired remote monitoring transmitter||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Remote Interrogation of Implantable Cardiac Devices in Rural Emergency Departments|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
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 Name: SJM Merlin@home remote monitoring transmitter
No Intervention: Interrogation with Programmer
Interrogation with programmer Interrogation with programmer according to usual standard of care
- Time to Clinical Specialist Treatment Decision [ Time Frame: 1 day ]ED check in time to time of clinical specialist treatment decision.
- 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.
- Time to Device Interrogation [ Time Frame: 1 day ]ED check in time until time of device interrogation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421549
|United States, New Mexico|
|New Mexico Heart Institute|
|Albuquerque, New Mexico, United States, 87102|
|Principal Investigator:||Ross Downey, MD||New Mexico Heart Institute, PA|