Arrhythmias, Cardiac, Cardiovascular Disease, Heart Disease, Heart Failure
Conditions
Keywords
Remote Monitoring, Remote Care, Cardiac Resynchronization Therapy, Pacemaker, Implantable Cardioverter Defibrillator
Brief summary
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.
Interventions
Unpaired remote monitoring transmitter
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Present to Emergency Department with an implanted pacemaker or defibrillator. 2. Are 18 years of age or older, or of legal age to give informed consent specific to state law. 3. Are willing and able to provide informed consent for study participation.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Interrogation | On day of Emergency Department admission | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Clinical/Treatment Decision | On day of Emergency Department admission | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of Emergency Department Stay | On day of Emergency Department admission | 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). |
Countries
United States
Participant flow
Recruitment details
Subjects enrolled from 20-September-2013 to 14-April-2015 from the Genesis Healthcare Emergency Department located in Zanesville, Ohio.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Interrogation With Unpaired Remote Monitoring Transmitter Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.
Unpaired remote monitoring transmitter | 35 |
| Interrogation With Programmer Interrogation with programmer according to usual standard of care | 48 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Interrogation not completed correctly | 1 | 0 |
| Overall Study | Interrogation not done in Emergency Room | 1 | 22 |
| Overall Study | Subject Non-Compliance | 0 | 1 |
Baseline characteristics
| Characteristic | Interrogation With Unpaired Remote Monitoring Transmitter | Interrogation With Programmer | Total |
|---|---|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 18.6 | 64.4 years STANDARD_DEVIATION 14.7 | 65.5 years STANDARD_DEVIATION 16.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 41 Participants | 74 Participants |
| Sex: Female, Male Female | 17 Participants | 7 Participants | 24 Participants |
| Sex: Female, Male Male | 18 Participants | 41 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 35 | 0 / 48 |
| serious Total, serious adverse events | 0 / 35 | 0 / 48 |
Outcome results
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.
Time frame: On day of Emergency Department admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interrogation With Unpaired Remote Monitoring Transmitter | Time to Interrogation | 25 Minutes |
| Interrogation With Programmer | Time to Interrogation | 210 Minutes |
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).
Time frame: On day of Emergency Department admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interrogation With Unpaired Remote Monitoring Transmitter | Time to Clinical/Treatment Decision | 204 Minutes |
| Interrogation With Programmer | Time to Clinical/Treatment Decision | 270 Minutes |
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).
Time frame: On day of Emergency Department admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interrogation With Unpaired Remote Monitoring Transmitter | Length of Emergency Department Stay | 261 Minutes |
| Interrogation With Programmer | Length of Emergency Department Stay | 245 Minutes |