Heart FailurePRoMOTE FUNCT03009175
PRoMOTE Follow-up Observational Study
An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure.
Trial summary
The purpose of the study is: To evaluate the Heart Failure Risk Status (HFRS) feature performance. To establish the feasibility of remote follow-up in which patient risk triaging is performed by nurse-led review of HFRS feature as supplemental information. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/Pacemaker
- Type of treatment
- Medical device
- How many people
- 287 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Aug 2014
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will include patients of both sexes included in the Medtronic CareLink® Network and implanted with a Medtronic wireless implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy device with defibrillation capabilities device (CRT-D) at Hospital Araba (former Hospital Txagorritxu). There are approximately 223 ICD and CRT-D patients included in the CareLink® Network at this site, and average number of transmissions per month is ~80, so it is expected that 480 transmissions are received during the study duration. From this population, less than 10% are implanted with a device without Optivol® feature. For these patients we will not have HFRS data.
Who may be able to join
- Patients that meet all of following criteria could be included in the study:
- Implant of a commercially available Medtronic CRTD or ICD device with or without the Optivol Fluid Status Monitoring feature.
- Local consent available for CL network as well as general local consent available for the use of data in observational studies signed and informative sheet delivered.
Who cannot join
- Patients under the age of 18 years.
About this study
Official title: Patient Risk Triage in ICD Remote Follow-up Observational Study (PRoMOTE FU)
The purpose of the study is:
- To evaluate the Heart Failure Risk Status (HFRS) feature performance.
- To establish the feasibility of remote follow-up in which patient risk triaging is performed by nurse-led review of HFRS feature as supplemental information.
- Conditions
- Heart Failure
- Being tested
- Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/Pacemaker
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/PacemakerDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Data collected through the phone call to the patients during the 6 months of study duration will be correlated to the HF risk classification provided by the HFRS feature on each transmission.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startJun 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009175
- Sponsor's protocol ID
- PRoMOTE FU
- Acronym
- PRoMOTE FU
- Status last verified
- Jun 2025
- First submitted
- 11 Jan 2016
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Risk Triage in ICD Remote Follow-up Observational Study (PRoMOTE FU)
- ClinicalTrials.gov ID
- NCT03009175
- Acronym / sponsor ID
- PRoMOTE FU / PRoMOTE FU
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 4 Jan 2017 (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.
The purpose of the study is:
- To evaluate the Heart Failure Risk Status (HFRS) feature performance.
- To establish the feasibility of remote follow-up in which patient risk triaging is performed by nurse-led review of HFRS feature as supplemental information.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include patients of both sexes included in the Medtronic CareLink® Network and implanted with a Medtronic wireless implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy device with defibrillation capabilities device (CRT-D) at Hospital Araba (former Hospital Txagorritxu). There are approximately 223 ICD and CRT-D patients included in the CareLink® Network at this site, and average number of transmissions per month is ~80, so it is expected that 480 transmissions are received during the study duration. From this population, less than 10% are implanted with a device without Optivol® feature. For these patients we will not have HFRS data.
Key inclusion criteria (3 listed)
- Implant of a commercially available Medtronic CRTD or ICD device with or without the Optivol Fluid Status Monitoring feature.
- Local consent available for CL network as well as general local consent available for the use of data in observational studies signed and informative sheet delivered.
Key exclusion criteria (1 listed)
- Patients under the age of 18 years.
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 |
|---|---|---|
| Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/Pacemaker | Device | – |
Primary outcome
Clinical Data collected through the phone call to the patients during the 6 months of study duration will be correlated to the HF risk classification provided by the HFRS feature on each transmission.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure.
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 3 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: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Data collected through the phone call to the patients during the 6 months of study duration will be correlated to the HF risk classification provided by the HFRS feature on each transmission. (time frame: 6 months). 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 2 Jul 2025.