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Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
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.
Conditions:
🦠 Heart Failure NYHA Class II 🦠 Heart Failure NYHA Class III
🗓️ Study Start (Actual) 3 September 2020
🗓️ Primary Completion (Estimated) April 2025
✅ Study Completion (Estimated) April 2025
👥 Enrollment (Estimated) 900
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Mesa, Arizona, United States
📍 Jonesboro, Arkansas, United States
📍 Mission Viejo, California, United States
📍 Oxnard, California, United States
📍 Stockton, California, United States
📍 Littleton, Colorado, United States
📍 Boca Raton, Florida, United States
📍 Brandon, Florida, United States
📍 Fort Pierce, Florida, United States
📍 Jacksonville, Florida, United States
📍 Jacksonville, Florida, United States
📍 Leesburg, Florida, United States
📍 Pensacola, Florida, United States
📍 Saint Petersburg, Florida, United States
📍 Tallahassee, Florida, United States
📍 Savannah, Georgia, United States
📍 Evanston, Illinois, United States
📍 Urbana, Illinois, United States
📍 Fort Wayne, Indiana, United States
📍 Indianapolis, Indiana, United States
📍 West Des Moines, Iowa, United States
📍 Kansas City, Kansas, United States
📍 Edgewood, Kentucky, United States
📍 Louisville, Kentucky, United States
📍 Louisville, Kentucky, United States
📍 Shreveport, Louisiana, United States
📍 Robbinsdale, Minnesota, United States
📍 Jackson, Mississippi, United States
📍 Tupelo, Mississippi, United States
📍 Columbia, Missouri, United States
📍 Lincoln, Nebraska, United States
📍 Omaha, Nebraska, United States
📍 Voorhees, New Jersey, United States
📍 Albuquerque, New Mexico, United States
📍 Brooklyn, New York, United States
📍 New York, New York, United States
📍 Poughkeepsie, New York, United States
📍 Roslyn, New York, United States
📍 Stony Brook, New York, United States
📍 Greensboro, North Carolina, United States
📍 Wilmington, North Carolina, United States
📍 Cincinnati, Ohio, United States
📍 Columbus, Ohio, United States
📍 Columbus, Ohio, United States
📍 Doylestown, Pennsylvania, United States
📍 Philadelphia, Pennsylvania, United States
📍 Charleston, South Carolina, United States
📍 Columbia, South Carolina, United States
📍 Germantown, Tennessee, United States
📍 Memphis, Tennessee, United States
📍 Fort Worth, Texas, United States
📍 Tyler, Texas, United States
📍 Charlottesville, Virginia, United States
📍 Norfolk, Virginia, United States
📍 Seattle, Washington, United States
📍 Tacoma, Washington, United States
📍 Charleston, West Virginia, United States
📍 Morgantown, West Virginia, United States
More locations available...

📋 Eligibility Criteria

Description

    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 as meeting any one of the following three criteria: 1. Hospital admission with primary diagnosis of HF within the last 12 months, OR 2. Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration within the last 6 months, OR 3. Patient had 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 or NT-proBNP \> 900 pg/ml
    • * Patient is willing and able to comply with the protocol, including LINQ ICM insertion, CareLink transmissions (including adequate connectivity), study visits and remote care directions.
    • * Patient is 18 years of age or older.
    • * Patient has a life expectancy of 12 months or more.

    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 days of 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 or amyloidosis.
    • * 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 must have a negative pregnancy test within 1 week of enrollment).
    • * Patient is enrolled in another interventional study.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 June 2020
  • First Submitted that Met QC Criteria 26 June 2020
  • First Posted 30 June 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 July 2024
  • Last Update Posted 30 July 2024
  • Last Verified April 2024
I'm interested ...!!