An interventional study of Unpaired remote monitoring transmitter in Heart Disease, Cardiovascular Disease and Heart Failure, sponsored by Abbott Medical Devices. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Diagnostic
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.
This study's enrollment of 99 is close to the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.
Device: Unpaired remote monitoring transmitter
Interrogation with programmer according to usual standard of care
Unpaired remote monitoring transmitter
Also known as: St. Jude Medical Merlin@home remote monitoring transmitter
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.
Time frame: On day of Emergency Department admission
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).
Time frame: On day of Emergency Department admission
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).
Time frame: On day of Emergency Department admission
Subjects enrolled from 20-September-2013 to 14-April-2015 from the Genesis Healthcare Emergency Department located in Zanesville, Ohio.
| Milestone | Interrogation With Unpaired Remote Monitoring Transmitter | Interrogation With Programmer |
|---|---|---|
| Started | 35 | 48 |
| Completed | 33 | 25 |
| Not completed | 2 | 23 |
| Withdrew: Interrogation not done in emergency room | 1 | 22 |
| Withdrew: Interrogation not completed correctly | 1 | 0 |
| Withdrew: Subject non-compliance | 0 | 1 |
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.
| Minutes | Interrogation With Unpaired Remote Monitoring Transmitter | Interrogation With Programmer |
|---|---|---|
| Time to Interrogation | 25 (1 to 95) | 210 (1 to 980) |
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).
| Minutes | Interrogation With Unpaired Remote Monitoring Transmitter | Interrogation With Programmer |
|---|---|---|
| Time to Clinical/Treatment Decision | 204 (67 to 354) | 270 (24 to 874) |
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).
| Minutes | Interrogation With Unpaired Remote Monitoring Transmitter | Interrogation With Programmer |
|---|---|---|
| Length of Emergency Department Stay | 261 (109 to 547) | 245 (66 to 874) |
Collected over Adverse Events were reported while subject was in the Emergency Department.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interrogation With Unpaired Remote Monitoring Transmitter | — | 0/35 (0%) | 1/35 (2.9%) |
| Interrogation With Programmer | — | 0/48 (0%) | 0/48 (0%) |
| Event | Interrogation With Unpaired Remote Monitoring Transmitter | Interrogation With Programmer |
|---|---|---|
| Failed transmission from the study device to fax, email, or Merlin.NetInjury, poisoning and procedural complications | 1/35 | 0/48 |
| Age, Continuous(years) | Interrogation With Unpaired Remote Monitoring Transmitter | Interrogation With Programmer | Total |
|---|---|---|---|
| Mean | 67.1 ± 18.6 | 64.4 ± 14.7 | 65.5 ± 16.4 |
| Sex: Female, Male(Participants) | Interrogation With Unpaired Remote Monitoring Transmitter | Interrogation With Programmer | Total |
|---|---|---|---|
| Female | 17 | 7 | 24 |
| Male | 18 | 41 | 59 |
| Race (NIH/OMB)(Participants) | Interrogation With Unpaired Remote Monitoring Transmitter | Interrogation With Programmer | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 5 | 6 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 33 | 41 | 74 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Plan to share: No
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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