Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
NCT ID: NCT04452149
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
826 participants
INTERVENTIONAL
2020-09-03
2025-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Observation Arm
Subjects will receive a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download, and will be managed per standard of care for heart failure management without visibility to the heart failure sensor data. Subjects will transition to the intervention arm after 13 months.
Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download
Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download.
Intervention Arm
Subjects will receive a Reveal LINQ™ Insertable Cardiac Monitor with an investigational ALLEVIATE-HF RAMware download, and will be managed using an integrated device diagnostic-based risk stratification algorithm combined with a clinical medication plan.
Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download
Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download.
Medication intervention
Risk status guided medication intervention.
Interventions
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Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download
Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download.
Medication intervention
Risk status guided medication intervention.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Javed Butler, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor Scott and White Health
Locations
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Cardiovascular Associates of Mesa
Mesa, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Saint Joseph Heritage Healthcare
Mission Viejo, California, United States
Cardiology Associates Medical Group
Oxnard, California, United States
Saint Joseph's Medical Center
Stockton, California, United States
South Denver Cardiology Associates
Littleton, Colorado, United States
FWD Clinical Research LLC
Boca Raton, Florida, United States
Bay Area Cardiology Associates PA
Brandon, Florida, United States
Florida Heart Center
Ft. Pierce, Florida, United States
Baptist Health
Jacksonville, Florida, United States
First Coast Cardiovascular Institute PA
Jacksonville, Florida, United States
Citrus Cardiology Consultants PA
Leesburg, Florida, United States
Baptist Hospital
Pensacola, Florida, United States
Northside Hospital
St. Petersburg, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
NorthShore University Health System
Evanston, Illinois, United States
Carle Foundation Hospital
Urbana, Illinois, United States
Parkview Health
Fort Wayne, Indiana, United States
Ascension Medical Group - Saint Vincent
Indianapolis, Indiana, United States
Iowa Heart Center
West Des Moines, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Saint Elizabeth Healthcare
Edgewood, Kentucky, United States
Baptist Healthcare System
Louisville, Kentucky, United States
Norton Healthcare
Louisville, Kentucky, United States
North Memorial Health Heart & Vascular Center
Robbinsdale, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, United States
CHI Health Creighton University Medical Center - Bergan Mercy
Omaha, Nebraska, United States
Lourdes Cardiology Services
Voorhees Township, New Jersey, United States
New Mexico Heart Institute PA
Albuquerque, New Mexico, United States
Columbia University Irving Medical Center/NYPH
New York, New York, United States
Hudson Valley Heart Center
Poughkeepsie, New York, United States
Saint Francis Hospital
Roslyn, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Cone Health
Greensboro, North Carolina, United States
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, United States
The Lindner Research Center
Cincinnati, Ohio, United States
Mount Carmel East
Columbus, Ohio, United States
OhioHealth Research and Innovation Institute (OHRI)
Columbus, Ohio, United States
Doylestown Health Cardiology a division of Doylestown Health Physicians
Doylestown, Pennsylvania, United States
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health Midlands
Columbia, South Carolina, United States
The Stern Cardiovascular Foundation
Germantown, Tennessee, United States
University of Tennessee Methodist Physicians
Memphis, Tennessee, United States
Medical City Fort Worth
Fort Worth, Texas, United States
Tyler Cardiovascular Consultants
Tyler, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Swedish Medical Center Cherry Hill
Seattle, Washington, United States
Saint Joseph Medical Center (Tacoma WA)
Tacoma, Washington, United States
Charleston Area Medical Center (CAMC) Memorial Hospital
Charleston, West Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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References
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Kahwash R, Zile MR, Chalasani P, Bertolet B, Gravelin L, Khan MS, Wehking J, Van Dorn B, Sarkar S, Laager V, Gerritse B, Laechelt A, Butler J; ALLEVIATE-HF Phase I Investigators. Personalized Intervention Strategy Based on a Risk Score Generated From Subcutaneous Insertable Cardiac Monitor: Results From Phase 1 of ALLEVIATE-HF. J Am Heart Assoc. 2024 Oct 15;13(20):e035501. doi: 10.1161/JAHA.124.035501. Epub 2024 Oct 11.
Zile MR, Kahwash R, Sarkar S, Koehler J, Zielinski T, Mehra MR, Fonarow GC, Gulati S, Butler J. A Novel Heart Failure Diagnostic Risk Score Using a Minimally Invasive Subcutaneous Insertable Cardiac Monitor. JACC Heart Fail. 2024 Jan;12(1):182-196. doi: 10.1016/j.jchf.2023.09.014. Epub 2023 Nov 8.
Other Identifiers
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ALLEVIATE-HF
Identifier Type: -
Identifier Source: org_study_id
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