Heart FailureLINQ HFNCT02758301
Reveal LINQ™ Heart Failure
An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 19 sites in United States.
Trial summary
The purpose of the LINQ™ HF study is to characterize Reveal LINQ™ derived data from patients with heart failure by assessing the relationship between changes in LINQ™ derived data and other physiologic parameters with subsequent acute decompensated heart failure (ADHF) events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Reveal LINQ™ Insertable Cardiac Monitor (ICM)
- Type of treatment
- Medical device
- How many people
- 112 participants
- Where
- 19 sitesUnited States
- Study dates
- 8 Jun 2016to 4 Dec 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: The subject population for the LINQ™ HF study is patients with heart failure with a NYHA Class III who meet all of the inclusion and none of the exclusion criteria.
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 protocol, including follow-up visits and CareLink transmissions
- Patient is NYHA Class III, per most recent assessment or at any time within 30 days prior to enrollment
- Patient had a HF event (HF event defined as meeting any one of the following three criteria):
- Admission with primary diagnosis of HF within the last 6 months, OR
Show all 15Show fewer
- Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings within the last 6 months:
- Admission with secondary/tertiary diagnosis of HF
- Emergency Department
- Ambulance
- Observation Unit
- Urgent Care
- HF/Cardiology Clinic
- Patient's Home, OR
- Patient had the following BNP/NTpro-BNP within the last 3 months: If EF ≥ 50%, then BNP> 200 pg/ml or NTpro-BNP > 400 pg/ml OR If EF <50%, then BNP> 400 pg/ml or NTpro-BNP > 800 pg/ml
Who cannot join
- Patient is pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
- Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager
- Patient has severe valvular heart disease as defined by hemodynamically significant valve stenosis and/or prosthetic heart valve
- Patient has existing IPG, ICD, CRT-D or CRT-P device
- Patient has severe renal impairment (eGFR <25mL/min)
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Austin Heart PA
Austin, Texas, 78756
Bay Area Cardiology Associates PA
Brandon, Florida, 33511
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Virginia
Charlottesville, Virginia, 22908
The Lindner Research Center
Cincinnati, Ohio, 45219
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Mid America Heart Institute
Kansas City, Missouri, 64111
Scripps Green Hospital
La Jolla, California, 92037
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Centra Medical Group Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501
Louisiana State University
New Orleans, Louisiana, 70112
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Oregon Health & Science University Hospital
Portland, Oregon, 97239
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303
Prairie Education & Research Cooperative
Springfield, Illinois, 62701
Washington University School of Medicine
St Louis, Missouri, 63110
Cardiology Associates of North Mississippi
Tupelo, Mississippi, 38801
Lourdes Cardiology Services
Voorhees Township, New Jersey, 08043
About this study
The purpose of the LINQ™ HF study is to characterize Reveal LINQ™ derived data from patients with heart failure by assessing the relationship between changes in LINQ™ derived data and other physiologic parameters with subsequent acute decompensated heart failure (ADHF) events.
Read the detailed description
The study is a prospective, non-randomized, multi-center, observational, pre-market clinical study. The study is expected to be conducted at up to 30 centers in the United States. Up to 300 subjects will be enrolled to achieve approximately 40 heart failure events (no more than two per subject will contribute to the cumulative total). Study subjects will be followed for up to 3 years post-insertion or until official study closure defined as when Medtronic and/or regulatory requirements have been satisfied per the Clinical Investigation Plan and/or by a decision by Medtronic or regulatory authority, whichever occurs first. The expected study duration is approximately 4 years representing 1.5 years of enrollments and 2.5 years of follow-up.
The LINQ™ HF study is a Non-Significant Risk Investigational Device Exemption (IDE) study. The study is utilizing the Reveal LINQ™ device with an investigational LINQ™ HF RAMware download.
- Conditions
- Heart Failure
- Being tested
- Reveal LINQ™ Insertable Cardiac Monitor (ICM)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reveal LINQ™ Insertable Cardiac Monitor (ICM)Device
Insertable Cardiac Monitor with LINQ™ HF Investigational RAMware download
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic | The Reveal LINQ™ Insertable Cardiac Monitor (ICM) device will be inserted in all subjects for continuous monitoring. After the Reveal LINQ™ device is inserted, the LINQ™ HF investigational RAMware will be downloaded to the LINQ™ ICM. Receives: Device: Reveal LINQ™ Insertable Cardiac Monitor (ICM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event
A heart failure (HF) event is defined as any cardiovascular-related Health Care Utilizations (HCUs) for any one of the following events.
- Admission with primary diagnosis of HF
- Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings:
- Admission with secondary/tertiary diagnosis of HF
- Emergency Department
- Ambulance
- Observation Unit
- Urgent Care
- HF/Cardiology Clinic
Up to 2 ADHF events were intended to be allowed per subject:
- One had to be at least 30 days post-Reveal LINQ insertion and is summarized in this section, and
- A possible second ADHF event must be greater than 90 days after the first ADHF event
Only subjects with a LINQ device were included in the analysis, as the goal was to acquire LINQ-collected data leading up to the ADHF event.
Measured: 30 days post-Reveal LINQ insertion to 3 years post-implant
Number of Participants With a LINQ Device Experiencing a Second Acute Decompensated Heart Failure (ADHF) Events
A heart failure (HF) event is defined as any cardiovascular-related Health Care Utilizations (HCUs) for any one of the following events.
- Admission with primary diagnosis of HF
- Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings:
- Admission with secondary/tertiary diagnosis of HF
- Emergency Department
- Ambulance
- Observation Unit
- Urgent Care
- HF/Cardiology Clinic
Up to two ADHF events per subject were intended to be evaluated. The first must be at least 30 days post-Reveal LINQ insertion, and the second, summarized in this section, must be greater than 90 days following the first ADHF event.
Only subjects with a LINQ device were included in the analysis, as the goal was to acquire LINQ-collected data leading up to the ADHF event.
Measured: > 90 days following first Acute Decompensated Heart Failure event to 3 years post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start8 Jun 2016
- Primary completion4 Dec 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 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
- NCT02758301
- Sponsor's protocol ID
- LINQ HF
- Acronym
- LINQ HF
- Status last verified
- Oct 2019
- First submitted
- 27 Apr 2016
- Last updated
- 12 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reveal LINQ™ Heart Failure
- ClinicalTrials.gov ID
- NCT02758301
- Acronym / sponsor ID
- LINQ HF / LINQ HF
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Posted 12 Nov 2019
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 LINQ™ HF study is to characterize Reveal LINQ™ derived data from patients with heart failure by assessing the relationship between changes in LINQ™ derived data and other physiologic parameters with subsequent acute decompensated heart failure (ADHF) events.
Detailed description
The study is a prospective, non-randomized, multi-center, observational, pre-market clinical study. The study is expected to be conducted at up to 30 centers in the United States. Up to 300 subjects will be enrolled to achieve approximately 40 heart failure events (no more than two per subject will contribute to the cumulative total). Study subjects will be followed for up to 3 years post-insertion or until official study closure defined as when Medtronic and/or regulatory requirements have been satisfied per the Clinical Investigation Plan and/or by a decision by Medtronic or regulatory authority, whichever occurs first. The expected study duration is approximately 4 years representing 1.5 years of enrollments and 2.5 years of follow-up.
The LINQ™ HF study is a Non-Significant Risk Investigational Device Exemption (IDE) study. The study is utilizing the Reveal LINQ™ device with an investigational LINQ™ HF RAMware download.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic | – | Device: Reveal LINQ™ Insertable Cardiac Monitor (ICM)The Reveal LINQ™ Insertable Cardiac Monitor (ICM) device will be inserted in all subjects for continuous monitoring. After the Reveal LINQ™ device is inserted, the LINQ™ HF investigational RAMware will be downloaded to the LINQ™ ICM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population for the LINQ™ HF study is patients with heart failure with a NYHA Class III who meet all of the inclusion and none of the exclusion criteria.
Key inclusion criteria (15 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 protocol, including follow-up visits and CareLink transmissions
- Patient is NYHA Class III, per most recent assessment or at any time within 30 days prior to enrollment
- Patient had a HF event (HF event defined as meeting any one of the following three criteria):
Key exclusion criteria (5 listed)
- Patient is pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
- Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager
- Patient has severe valvular heart disease as defined by hemodynamically significant valve stenosis and/or prosthetic heart valve
- Patient has existing IPG, ICD, CRT-D or CRT-P device
- Patient has severe renal impairment (eGFR <25mL/min)
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 |
|---|---|---|
| Reveal LINQ™ Insertable Cardiac Monitor (ICM)Insertable Cardiac Monitor with LINQ™ HF Investigational RAMware download | Device | Diagnostic |
Primary outcome
Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event
Time frame: 30 days post-Reveal LINQ insertion to 3 years post-implant
A heart failure (HF) event is defined as any cardiovascular-related Health Care Utilizations (HCUs) for any one of the following events. * Admission with primary diagnosis of HF * Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: 1. Admission with secondary/tertiary diagnosis of HF 2. Emergency Department 3. Ambulance 4. Observation Unit 5. Urgent Care 6. HF/Cardiology Clinic Up to 2 ADHF events were intended to be allowed per subject: 1. One had to be at least 30 days post-Reveal LINQ insertion and is summarized in this section, and 2. A possible second ADHF event must be greater than 90 days after the first ADHF event Only subjects with a LINQ device were included in the analysis, as the goal was to acquire LINQ-collected data leading up to the ADHF event.
Number of Participants With a LINQ Device Experiencing a Second Acute Decompensated Heart Failure (ADHF) Events
Time frame: > 90 days following first Acute Decompensated Heart Failure event to 3 years post-implant
A heart failure (HF) event is defined as any cardiovascular-related Health Care Utilizations (HCUs) for any one of the following events. * Admission with primary diagnosis of HF * Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: 1. Admission with secondary/tertiary diagnosis of HF 2. Emergency Department 3. Ambulance 4. Observation Unit 5. Urgent Care 6. HF/Cardiology Clinic Up to two ADHF events per subject were intended to be evaluated. The first must be at least 30 days post-Reveal LINQ insertion, and the second, summarized in this section, must be greater than 90 days following the first ADHF event. Only subjects with a LINQ device were included in the analysis, as the goal was to acquire LINQ-collected data leading up to the ADHF event.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingObservational study
Heart Failure and Aortic Stenosis Transcriptome
Heart Failure, Aortic Stenosis
Active, not recruiting
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Left Ventricular Ejection Fraction, Heart Failure (HF)
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
Recruiting
Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
Heart Failure, Cardiovascular Risk Factors
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.
19 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 Cardiac Rhythm and Heart Failure at 19 sites 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 15 inclusion and 5 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 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event (time frame: 30 days post-Reveal LINQ insertion to 3 years post-implant). The study lists 2 primary outcomes in all. 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 12 Nov 2019.