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Reveal LINQ™ Heart Failure (NCT02758301)

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.
  • Device: Reveal LINQ™ Insertable Cardiac Monitor (ICM)
    Insertable Cardiac Monitor with LINQ™ HF Investigational RAMware download
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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)
    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.

    21 locations

    United States (21)
    • Scripps Green Hospital
      active not recruiting
      La Jolla, California, United States, 92037
    • Bay Area Cardiology Associates PA
      recruiting
      Brandon, Florida, United States, 33511
    • Prairie Education & Research Cooperative
      active not recruiting
      Springfield, Illinois, United States, 62701
    • Louisiana State University
      active not recruiting
      New Orleans, Louisiana, United States, 70112
    • Sparrow Clinical Research Institute
      completed
      Lansing, Michigan, United States, 48912
    • CentraCare Heart & Vascular Center
      completed
      Saint Cloud, Minnesota, United States, 56303
    • Cardiology Associates of North Mississippi
      recruiting
      Tupelo, Mississippi, United States, 38801
    • Mid America Heart Institute
      active not recruiting
      Kansas City, Missouri, United States, 64111
    • Washington University School of Medicine
      active not recruiting
      Saint Louis, Missouri, United States, 63110
    • Lourdes Cardiology Services
      recruiting
      Voorhees, New Jersey, United States, 08043
    • Carolinas Medical Center
      recruiting
      Charlotte, North Carolina, United States, 28203
    • The Lindner Research Center
      active not recruiting
      Cincinnati, Ohio, United States, 45219
    • The Ohio State University Wexner Medical Center
      recruiting
      Columbus, Ohio, United States, 43210
    • Oregon Health & Science University Hospital
      active not recruiting
      Portland, Oregon, United States, 97239
    • Lancaster General Hospital
      recruiting
      Lancaster, Pennsylvania, United States, 17602
    • Austin Heart PA
      active not recruiting
      Austin, Texas, United States, 78756
    • University of Virginia
      active not recruiting
      Charlottesville, Virginia, United States, 22908
    • Centra Medical Group Stroobants Cardiovascular Center
      active not recruiting
      Lynchburg, Virginia, United States, 24501
    • Sentara Norfolk General Hospital
      active not recruiting
      Norfolk, Virginia, United States, 23507
    • Orlando Regional Medical Center Orlando Health
      withdrawn
      Orlando, Florida, United States, 32806
    • Hospital of the University of Pennsylvania
      withdrawn
      Philadelphia, Pennsylvania, United States, 19104
    Status:
    recruiting
    Type:
    Observational
    Phase:
    -
    Start:
    07 June, 2016
    Updated:
    20 March, 2018
    Participants:
    106
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