Remote Interrogation of Implantable Cardiac Devices in Rural Emergency Departments
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Abbott Medical Devices
- Locations
- 1
- Primary Endpoint
- Time to Clinical Specialist Treatment Decision
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Are unwilling to provide written informed consent.
Arms & Interventions
Interrogation with Programmer
Interrogation with programmer Interrogation with programmer according to usual standard of care
Interrogation with unpaired remote monitoring transmitter
Interrogation with unpaired remote monitoring transmitter Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.
Intervention: Unpaired remote monitoring transmitter (Device)
Outcomes
Primary Outcomes
Time to Clinical Specialist Treatment Decision
Time Frame: 1 day
ED check in time to time of clinical specialist treatment decision.
Secondary Outcomes
- Health Care Utilization Rate(Within 30 days of initial ED visit)