Heart FailureNCT01798797
Integrated Diagnostic for Heart Failure
An observational study of Heart Failure, run by Medtronic at 3 sites in Canada.
Trial summary
A prospective post-market study to evaluate the performance and clinic usability of heart failure risk status (HFRS) feature on CareLink. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 100 participants
- Where
- 3 sitesCanada
- Study dates
- Aug 2013to Jul 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with heart failure who have been implanted with an ICD or a CRT-D wirless device for at least 3 months
Who may be able to join
- Patient is 18 years of age or older
- Patient ( or patient's legally authorized representative) is willing and able to provide written informed consent
- Patient is willing and able to comply with the required study follow up visits
- Patient is implanted with a Medtronic wireless ICD or CRT-D device capable of OptiVol fluid monitoring feature
- Patient is on Medtronic CareLink network or is willing to be enrolled on the CareLink network
- Patient is being managed, or has been managed, by a HF clinician
Show all 9Show fewer
- Patient has signed an informed consent for CareLink Network Services
- Patient is implanted with device for at least three months
- Patient is willing and able to transmit data using the CareLink home monitor (2490C).
Who cannot join
- Patient is participating in another study that may interfere with TRIAGE-HF protocol required procedures
- Patient with an implantable cardiac device that is indicated to reach ERI in less than 12 months
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
A prospective post-market study to evaluate the performance and clinic usability of heart failure risk status (HFRS) feature on CareLink.
Read the detailed description
Patients with systolic heart failure (HF) implanted with Medtronic wireless implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy device with defibrillation capabilities (CRT-D) devices will be enrolled in the study. The purpose of the study is to evaluate the usability of CareLink HFRS to manage a patient's heart failure.
- Conditions
- Heart Failure
- Keywords
- Heart Failure, HFRS, OptiVol, ICD, CRT-D
- Medical subject headings
- Heart Failure, Hemorrhagic Fever with Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| no treatment | non-randomized, all subjects who have been implanted with an ICD or CRT-D for at least 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Failure Risk Status Performance Characterization
The clinical signs and symptoms of worsening HF that are associated with an Heart Failure Risk Status triggered by an OptiVol alert
Measured: from baseline until a subject completes 8 months of follow up
Secondary outcomes (1)
Heart Failure Risk Status and medical management
The correlation between HFRS burden and clinician's assessment of a subject risk and the subject's medical management
Measured: from baseline for each subject until they complete 8 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2015
- Study completionJul 2015
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.
- More trials run by MedtronicThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Virani, MD, Principal investigator, Vancouver General Hospital, Vancouver, British Columbia, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798797
- Sponsor's protocol ID
- TRIAGE-HF
- Status last verified
- Sep 2018
- First submitted
- 14 Feb 2013
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Diagnostic for Heart Failure
- ClinicalTrials.gov ID
- NCT01798797
- Acronym / sponsor ID
- TRIAGE-HF
- Conditions
- Heart Failure
- Keywords
- Heart Failure, HFRS, OptiVol, ICD, CRT-D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- Aug 2013 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Feb 2013 (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 prospective post-market study to evaluate the performance and clinic usability of heart failure risk status (HFRS) feature on CareLink.
Detailed description
Patients with systolic heart failure (HF) implanted with Medtronic wireless implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy device with defibrillation capabilities (CRT-D) devices will be enrolled in the study. The purpose of the study is to evaluate the usability of CareLink HFRS to manage a patient's heart failure.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treatment | – | –non-randomized, all subjects who have been implanted with an ICD or CRT-D for at least 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with heart failure who have been implanted with an ICD or a CRT-D wirless device for at least 3 months
Key inclusion criteria (9 listed)
- Patient is 18 years of age or older
- Patient ( or patient's legally authorized representative) is willing and able to provide written informed consent
- Patient is willing and able to comply with the required study follow up visits
- Patient is implanted with a Medtronic wireless ICD or CRT-D device capable of OptiVol fluid monitoring feature
- Patient is on Medtronic CareLink network or is willing to be enrolled on the CareLink network
Key exclusion criteria (2 listed)
- Patient is participating in another study that may interfere with TRIAGE-HF protocol required procedures
- Patient with an implantable cardiac device that is indicated to reach ERI in less than 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart Failure Risk Status Performance Characterization
Time frame: from baseline until a subject completes 8 months of follow up
The clinical signs and symptoms of worsening HF that are associated with an Heart Failure Risk Status triggered by an OptiVol alert
1 secondary outcome
Heart Failure Risk Status and medical management
Time frame: from baseline for each subject until they complete 8 months of follow up
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 25 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingPhase 3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
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.
Sean Virani, MD principal investigator
Vancouver General Hospital, Vancouver, British Columbia, Canada
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Medtronic at 3 sites in Canada.
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 9 inclusion and 2 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 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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.
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?
Heart Failure Risk Status Performance Characterization (time frame: from baseline until a subject completes 8 months of follow up). 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 25 Sep 2018.