Reveal LINQ™ Heart Failure (LINQ HF)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Reveal LINQ™ Insertable Cardiac Monitor (ICM)

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 Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Green Hospital
  • Florida
    • Brandon, Florida, United States, 33511
      • Bay Area Cardiology Associates PA
  • Illinois
    • Springfield, Illinois, United States, 62701
      • Prairie Education & Research Cooperative
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Sparrow Clinical Research Institute
  • Minnesota
    • Saint Cloud, Minnesota, United States, 56303
      • CentraCare Heart & Vascular Center
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Cardiology Associates of North Mississippi
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Mid America Heart Institute
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Voorhees, New Jersey, United States, 08043
      • Lourdes Cardiology Services
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Research Center
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University Hospital
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Hospital
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Heart PA
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Lynchburg, Virginia, United States, 24501
      • Centra Medical Group Stroobants Cardiovascular Center
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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):

  1. Admission with primary diagnosis of HF within the last 6 months, OR

  2. 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
  3. 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Reveal LINQ™ Insertable Cardiac Monitor (ICM); Insertable Cardiac Monitor with LINQ™ HF Investigational RAMware download

What is the study measuring?

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 HFEmergency DepartmentAmbulanceObservation UnitUrgent CareHF/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 HFEmergency DepartmentAmbulanceObservation UnitUrgent CareHF/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

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2016
• Primary Completion (Actual): December 4, 2018
• Study Completion (Actual): December 4, 2018

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: LINQ HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes