Heart DiseasePhase 4REM REDNCT02421549
Remote Interrogation in Rural Emergency Departments
A Phase 4 study testing Unpaired remote monitoring transmitter in people with Heart Disease and Cardiovascular Disease, run by Abbott Medical Devices at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease, Cardiovascular Disease, Heart Failure
- What is being tested?
- Unpaired remote monitoring transmitter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Are unwilling to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
About this study
Official title: Remote Interrogation of Implantable Cardiac Devices in Rural Emergency Departments
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.
- Being tested
- Unpaired remote monitoring transmitter
- Keywords
- Remote Monitoring, Remote Care, Cardiac Resynchronization Therapy, Pacemaker, Implantable Cardioverter Defibrillator
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases, Heart Failure, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unpaired remote monitoring transmitterDevice
Also called SJM Merlin@home remote monitoring transmitter
| Study group | Role | What they receive |
|---|---|---|
| Interrogation with unpaired remote monitoring transmitter | Active comparator | Interrogation with unpaired remote monitoring transmitter Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. Receives: Device: Unpaired remote monitoring transmitter |
| Interrogation with Programmer | No intervention | Interrogation with programmer Interrogation with programmer according to usual standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Clinical Specialist Treatment Decision
ED check in time to time of clinical specialist treatment decision.
Measured: 1 day
Secondary outcomes (1)
Health Care Utilization Rate
Device related hospitalizations, ED visits and unscheduled office visits/urgent care visits within 30 days of the initial ED visit.
Measured: Within 30 days of initial ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startDec 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ross Downey, MD, Principal investigator, New Mexico Heart Institute, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421549
- Sponsor's protocol ID
- 60054491
- Acronym
- REM RED
- Status last verified
- Jan 2019
- First submitted
- 13 Apr 2015
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Interrogation of Implantable Cardiac Devices in Rural Emergency Departments
- ClinicalTrials.gov ID
- NCT02421549
- Acronym / sponsor ID
- REM RED / 60054491
- Keywords
- Remote Monitoring, Remote Care, Cardiac Resynchronization Therapy, Pacemaker, Implantable Cardioverter Defibrillator
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interrogation with unpaired remote monitoring transmitter | Active comparator | Device: Unpaired remote monitoring transmitterInterrogation with unpaired remote monitoring transmitter Interrogation with an unpaired remote monitoring transmitter for devices that are compatible. |
| Interrogation with Programmer | No intervention | –Interrogation with programmer Interrogation with programmer according to usual standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Are unwilling to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unpaired remote monitoring transmitterAlso: SJM Merlin@home remote monitoring transmitter | Device | Interrogation with unpaired remote monitoring transmitter |
Primary outcome
Time to Clinical Specialist Treatment Decision
Time frame: 1 day
ED check in time to time of clinical specialist treatment decision.
1 secondary outcome
Health Care Utilization Rate
Time frame: Within 30 days of initial ED visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ross Downey, MD principal investigator
New Mexico Heart Institute, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Unpaired remote monitoring transmitter in people with Heart Disease and Cardiovascular Disease, run by Abbott Medical Devices at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Clinical Specialist Treatment Decision (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.