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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interrogation with unpaired remote transmitter | Active Comparator | Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. |
|
| Interrogation with programmer | No Intervention | Interrogation with programmer according to usual standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unpaired remote monitoring transmitter | Device | Unpaired remote monitoring transmitter |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Emergency Department Stay | 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). | On day of Emergency Department admission |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Girsky, MD | Los Angeles Biomedical Research Institute at Harbor - UCLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis Healthcare System | Zanesville | Ohio | 43701 | United States |
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There were 16 screen failures because at the time of their enrollment, the patient group had met maximum enrollment for their patient group (compatible vs. non-compatible cardiac device) under the initial protocol.
Subjects enrolled from 20-September-2013 to 14-April-2015 from the Genesis Healthcare Emergency Department located in Zanesville, Ohio.
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| ID | Title | Description |
|---|---|---|
| FG000 | Interrogation With Unpaired Remote Monitoring Transmitter | Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Unpaired remote monitoring transmitter |
| FG001 | Interrogation With Programmer | Interrogation with programmer according to usual standard of care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interrogation With Unpaired Remote Monitoring Transmitter | Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Unpaired remote monitoring transmitter |
| BG001 | Interrogation With Programmer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | Minutes | On day of Emergency Department admission |
|
Adverse Events were reported while subject was in the Emergency Department.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interrogation With Unpaired Remote Monitoring Transmitter | Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Unpaired remote monitoring transmitter |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Failed transmission from the study device to fax, email, or Merlin.Net | Injury, poisoning and procedural complications | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Todd Stirman, Clinical Manager | St Jude Medical, Inc. | (972) 526-9625 | Tstirman@sjm.com |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006333 | Heart Failure |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Subject Non-Compliance |
|
Interrogation with programmer according to usual standard of care
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | 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). | Posted | Median | Full Range | Minutes | On day of Emergency Department admission |
|
|
|
| Other Pre-specified | Length of Emergency Department Stay | 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). | Posted | Median | Full Range | Minutes | On day of Emergency Department admission |
|
|
|
| 0 |
| 35 |
| 1 |
| 35 |
| EG001 | Interrogation With Programmer | Interrogation with programmer according to usual standard of care | 0 | 48 | 0 | 48 |
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