Reveal LINQ™ Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reveal LINQ™ Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Reveal LINQ™ Insertable Cardiac Monitor (ICM)


Participation Criteria
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Eligibility Criteria
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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 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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic<br>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. | Device: Reveal LINQ™ Insertable Cardiac Monitor (ICM)<br>* Insertable Cardiac Monitor with LINQ™ HF Investigational RAMware download<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | > 90 days following first Acute Decompensated Heart Failure event to 3 years post-implant |