Reveal LINQ™ Heart Failure (LINQ HF)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02758301 |
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Recruitment Status :
Completed
First Posted : May 2, 2016
Results First Posted : November 12, 2019
Last Update Posted : November 12, 2019
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| Condition or disease | Intervention/treatment |
|---|---|
| Heart Failure | Device: Reveal LINQ™ Insertable Cardiac Monitor (ICM) |
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 Type : | Observational |
| Actual Enrollment : | 112 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Reveal LINQ™ Heart Failure |
| Actual Study Start Date : | June 8, 2016 |
| Actual Primary Completion Date : | December 4, 2018 |
| Actual Study Completion Date : | December 4, 2018 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Device: Reveal LINQ™ Insertable Cardiac Monitor (ICM)
Insertable Cardiac Monitor with LINQ™ HF Investigational RAMware download |
- 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
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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.
- 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
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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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
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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
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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
Exclusion Criteria:
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758301
Show 19 study locations
Documents provided by Medtronic Cardiac Rhythm and Heart Failure:
| Responsible Party: | Medtronic Cardiac Rhythm and Heart Failure |
| ClinicalTrials.gov Identifier: | NCT02758301 |
| Other Study ID Numbers: |
LINQ HF |
| First Posted: | May 2, 2016 Key Record Dates |
| Results First Posted: | November 12, 2019 |
| Last Update Posted: | November 12, 2019 |
| Last Verified: | October 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
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Heart Failure Heart Diseases Cardiovascular Diseases |