Remote Device Interrogation In The Emergency Department

Study Overview
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Brief Summary
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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.

Official Title
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Remote Device Interrogation In The Emergency Department

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: 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

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 transmitter<br>Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. | Device: Unpaired remote monitoring transmitter<br>* Unpaired remote monitoring transmitter<br>* Other names: St. Jude Medical Merlin@home remote monitoring transmitter;|
| No Intervention: Interrogation with programmer<br>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 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | On day of Emergency Department admission | 

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