Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure

Last updated: May 9, 2025
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Chest Pain

Heart Failure

Treatment

Medication intervention

Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download

Clinical Study ID

NCT04452149
ALLEVIATE-HF
  • Ages > 18
  • All Genders

Study Summary

The ALLEVIATE-HF study is a prospective, randomized, controlled, blinded, multi-site, interventional, investigational device exemption (IDE) pivotal study. The purpose of the study is to demonstrate the safety and efficacy of a patient management pathway that utilizes an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with NYHA class II and III heart failure, and to demonstrate the safety of the Reveal LINQ™ system and procedure in the study population.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient has NYHA Class II or III heart failure per most recent assessment,irrespective of left ventricular ejection fraction (LVEF)

  • Patient has documented recent history of symptomatic heart failure, defined asmeeting any one of the following three criteria: 1. Hospital admission with primarydiagnosis of HF within the last 12 months, OR 2. Intravenous HF therapy (e.g. IVdiuretics/vasodilators) or ultrafiltration within the last 6 months, OR 3. Patienthad the following BNP/NT-proBNP within the last 3 months: If LVEF ≥ 50%, then BNP> 150 pg/ml or NT-proBNP > 450 pg/ml OR If LVEF is <50%, then BNP> 300 pg/ml orNT-proBNP > 900 pg/ml

  • Patient is willing and able to comply with the protocol, including LINQ ICMinsertion, CareLink transmissions (including adequate connectivity), study visitsand remote care directions.

  • Patient is 18 years of age or older.

  • Patient has a life expectancy of 12 months or more.

Exclusion

Exclusion Criteria:

  • Patient is currently implanted with a cardiovascular implantable electronic device (CIED) (e.g. ICM, pacemaker, ICD, CRT-D or CRT-P device) or hemodynamic monitor.

  • Patient is receiving temporary or permanent mechanical circulatory support.

  • Patient had MI or PCI/CABG within past 90 days.

  • Patient has had a heart transplant, or is currently on heart transplant list.

  • Patient has severe valve stenosis on echocardiogram.

  • Patient has primary pulmonary hypertension (pre-capillary, WHO group 1,3,4,5).

  • Patient is on chronic intravenous inotropic drug therapy (e.g. dobutamine,milrinone).

  • Patient has severe renal impairment (eGFR <30 mL/min).

  • Patient has systolic blood pressure of < 90 mmHg at the time of enrollment.

  • Patient is on chronic renal dialysis.

  • Patient is unable to undergo one round of PRN medication intervention (i.e. 4 daysof increased diuretics dose).

  • Patient has liver disease, defined as AST/ALT >5x normal, or bilirubin >2x normal.

  • Patient has serum albumin < 3 g/dL.

  • Patient has hypertrophic obstructive cardiomyopathy, constrictive pericarditis oramyloidosis.

  • Patient has complex adult congenital heart disease.

  • Patient has active cancer involving chemotherapy and/or radiation therapy.

  • Patient weighs more than 500 pounds.

  • Patient is pregnant or breastfeeding (all females of child-bearing potential musthave a negative pregnancy test within 1 week of enrollment).

  • Patient is enrolled in another interventional study.

Study Design

Total Participants: 826
Treatment Group(s): 2
Primary Treatment: Medication intervention
Phase:
Study Start date:
September 03, 2020
Estimated Completion Date:
May 31, 2025

Study Description

The study will utilize the market released Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download. The study will enroll up to 900 subjects at up to 75 sites in the US. Subjects will be followed until the last enrolled subject is followed for 7 months or until the end of the study, whichever occurs first, or until time of study exit or death as applicable, but no longer than 36 months.

Connect with a study center

  • Cardiovascular Associates of Mesa

    Mesa, Arizona 85282
    United States

    Site Not Available

  • Arrhythmia Research Group

    Jonesboro, Arkansas 72410
    United States

    Site Not Available

  • Saint Joseph Heritage Healthcare

    Mission Viejo, California 92691
    United States

    Site Not Available

  • Cardiology Associates Medical Group

    Oxnard, California 93030
    United States

    Site Not Available

  • Saint Joseph&#39;s Medical Center

    Stockton, California 95204
    United States

    Site Not Available

  • Saint Joseph's Medical Center

    Stockton, California 95204
    United States

    Site Not Available

  • South Denver Cardiology Associates

    Littleton, Colorado 80120
    United States

    Site Not Available

  • FWD Clinical Research LLC

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Bay Area Cardiology Associates PA

    Brandon, Florida 33511
    United States

    Site Not Available

  • Florida Heart Center

    Fort Pierce, Florida 34950
    United States

    Site Not Available

  • Baptist Health

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • First Coast Cardiovascular Institute PA

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Citrus Cardiology Consultants PA

    Leesburg, Florida 34748
    United States

    Site Not Available

  • Baptist Hospital

    Pensacola, Florida 32501
    United States

    Site Not Available

  • Northside Hospital

    Saint Petersburg, Florida 33709
    United States

    Site Not Available

  • Tallahassee Research Institute

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Memorial Health University Medical Center

    Savannah, Georgia 31404
    United States

    Site Not Available

  • NorthShore University Health System

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Carle Foundation Hospital

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Parkview Health

    Fort Wayne, Indiana 46845
    United States

    Site Not Available

  • Ascension Medical Group - Saint Vincent

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Iowa Heart Center

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Saint Elizabeth Healthcare

    Edgewood, Kentucky 41017
    United States

    Site Not Available

  • Baptist Healthcare System

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • Norton Healthcare

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Advanced Cardiovascular Specialists

    Shreveport, Louisiana 71105
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • North Memorial Health Heart & Vascular Center

    Robbinsdale, Minnesota 55422
    United States

    Site Not Available

  • North Memorial Health Heart &amp; Vascular Center

    Robbinsdale, Minnesota 55422
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Cardiology Associates of North Mississippi

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Missouri Cardiovascular Specialists

    Columbia, Missouri 65201
    United States

    Site Not Available

  • CHI Health Nebraska Heart

    Lincoln, Nebraska 68526
    United States

    Site Not Available

  • CHI Health Creighton University Medical Center - Bergan Mercy

    Omaha, Nebraska 68124
    United States

    Site Not Available

  • Lourdes Cardiology Services

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • New Mexico Heart Institute PA

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • New York-Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York 11215
    United States

    Site Not Available

  • NYU Langone Hospital Long Island

    Mineola, New York 11501
    United States

    Site Not Available

  • Columbia University Irving Medical Center/NYPH

    New York, New York 10032
    United States

    Site Not Available

  • Hudson Valley Heart Center

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • Saint Francis Hospital

    Roslyn, New York 11576
    United States

    Site Not Available

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Cone Health

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Novant Health New Hanover Regional Medical Center

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • The Lindner Research Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Mount Carmel East

    Columbus, Ohio 43213
    United States

    Site Not Available

  • OhioHealth Research and Innovation Institute (OHRI)

    Columbus, Ohio 43214
    United States

    Site Not Available

  • The University of Toledo Medical Center

    Toledo, Ohio 43614
    United States

    Site Not Available

  • Doylestown Health Cardiology a division of Doylestown Health Physicians

    Doylestown, Pennsylvania 18901
    United States

    Site Not Available

  • Cardiology Consultants of Philadelphia

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Prisma Health Midlands

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • The Stern Cardiovascular Foundation

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Wellmont CVA Heart Institute

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • University of Tennessee Methodist Physicians

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • Medical City Fort Worth

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • University of Texas Health Sciences Center at Houston - Center for Advanced Heart Failure

    Houston, Texas 77030
    United States

    Site Not Available

  • Tyler Cardiovascular Consultants

    Tyler, Texas 75701
    United States

    Site Not Available

  • University of Virginia Medical Center

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Swedish Medical Center Cherry Hill

    Seattle, Washington 98122
    United States

    Site Not Available

  • Saint Joseph Medical Center (Tacoma WA)

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Charleston Area Medical Center (CAMC) Memorial Hospital

    Charleston, West Virginia 25304
    United States

    Site Not Available

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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