Remote Interrogation in Rural Emergency Departments

Study Overview
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Brief Summary
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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.

Official Title
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Remote Interrogation of Implantable Cardiac Devices in Rural Emergency Departments

Conditions
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Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac

Intervention / Treatment
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* Device: Unpaired remote monitoring transmitter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interrogation with unpaired remote monitoring transmitter<br>Interrogation with unpaired remote monitoring transmitter Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. | Device: Unpaired remote monitoring transmitter<br> <br> * Other names: SJM Merlin@home remote monitoring transmitter;|
| No Intervention: Interrogation with Programmer<br>Interrogation with programmer Interrogation with programmer according to usual standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Clinical Specialist Treatment Decision | ED check in time to time of clinical specialist treatment decision. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Care Utilization Rate | Device related hospitalizations, ED visits and unscheduled office visits/urgent care visits within 30 days of the initial ED visit. | Within 30 days of initial ED visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Resynchronization Therapy, Implantable Cardioverter Defibrillator, Remote Monitoring, Remote Care, Pacemaker