Phase
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
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Cardiovascular Associates of Mesa
Mesa, Arizona 85282
United StatesSite Not Available
Arrhythmia Research Group
Jonesboro, Arkansas 72410
United StatesSite Not Available
Saint Joseph Heritage Healthcare
Mission Viejo, California 92691
United StatesSite Not Available
Cardiology Associates Medical Group
Oxnard, California 93030
United StatesSite Not Available
Saint Joseph's Medical Center
Stockton, California 95204
United StatesSite Not Available
Saint Joseph's Medical Center
Stockton, California 95204
United StatesSite Not Available
South Denver Cardiology Associates
Littleton, Colorado 80120
United StatesSite Not Available
FWD Clinical Research LLC
Boca Raton, Florida 33486
United StatesSite Not Available
Bay Area Cardiology Associates PA
Brandon, Florida 33511
United StatesSite Not Available
Florida Heart Center
Fort Pierce, Florida 34950
United StatesSite Not Available
Baptist Health
Jacksonville, Florida 32207
United StatesSite Not Available
First Coast Cardiovascular Institute PA
Jacksonville, Florida 32256
United StatesSite Not Available
Citrus Cardiology Consultants PA
Leesburg, Florida 34748
United StatesSite Not Available
Baptist Hospital
Pensacola, Florida 32501
United StatesSite Not Available
Northside Hospital
Saint Petersburg, Florida 33709
United StatesSite Not Available
Tallahassee Research Institute
Tallahassee, Florida 32308
United StatesSite Not Available
Memorial Health University Medical Center
Savannah, Georgia 31404
United StatesSite Not Available
NorthShore University Health System
Evanston, Illinois 60201
United StatesSite Not Available
Carle Foundation Hospital
Urbana, Illinois 61801
United StatesSite Not Available
Parkview Health
Fort Wayne, Indiana 46845
United StatesSite Not Available
Ascension Medical Group - Saint Vincent
Indianapolis, Indiana 46260
United StatesSite Not Available
Iowa Heart Center
West Des Moines, Iowa 50266
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
Saint Elizabeth Healthcare
Edgewood, Kentucky 41017
United StatesSite Not Available
Baptist Healthcare System
Louisville, Kentucky 40207
United StatesSite Not Available
Norton Healthcare
Louisville, Kentucky 40217
United StatesSite Not Available
Advanced Cardiovascular Specialists
Shreveport, Louisiana 71105
United StatesSite Not Available
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
United StatesSite Not Available
North Memorial Health Heart & Vascular Center
Robbinsdale, Minnesota 55422
United StatesSite Not Available
North Memorial Health Heart & Vascular Center
Robbinsdale, Minnesota 55422
United StatesSite Not Available
University of Mississippi Medical Center
Jackson, Mississippi 39216
United StatesSite Not Available
Cardiology Associates of North Mississippi
Tupelo, Mississippi 38801
United StatesSite Not Available
Missouri Cardiovascular Specialists
Columbia, Missouri 65201
United StatesSite Not Available
CHI Health Nebraska Heart
Lincoln, Nebraska 68526
United StatesSite Not Available
CHI Health Creighton University Medical Center - Bergan Mercy
Omaha, Nebraska 68124
United StatesSite Not Available
Lourdes Cardiology Services
Voorhees, New Jersey 08043
United StatesSite Not Available
New Mexico Heart Institute PA
Albuquerque, New Mexico 87102
United StatesSite Not Available
New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York 11215
United StatesSite Not Available
NYU Langone Hospital Long Island
Mineola, New York 11501
United StatesSite Not Available
Columbia University Irving Medical Center/NYPH
New York, New York 10032
United StatesSite Not Available
Hudson Valley Heart Center
Poughkeepsie, New York 12601
United StatesSite Not Available
Saint Francis Hospital
Roslyn, New York 11576
United StatesSite Not Available
Stony Brook University Hospital
Stony Brook, New York 11794
United StatesSite Not Available
Cone Health
Greensboro, North Carolina 27401
United StatesSite Not Available
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina 28401
United StatesSite Not Available
The Lindner Research Center
Cincinnati, Ohio 45219
United StatesSite Not Available
Mount Carmel East
Columbus, Ohio 43213
United StatesSite Not Available
OhioHealth Research and Innovation Institute (OHRI)
Columbus, Ohio 43214
United StatesSite Not Available
The University of Toledo Medical Center
Toledo, Ohio 43614
United StatesSite Not Available
Doylestown Health Cardiology a division of Doylestown Health Physicians
Doylestown, Pennsylvania 18901
United StatesSite Not Available
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Prisma Health Midlands
Columbia, South Carolina 29203
United StatesSite Not Available
The Stern Cardiovascular Foundation
Germantown, Tennessee 38138
United StatesSite Not Available
Wellmont CVA Heart Institute
Kingsport, Tennessee 37660
United StatesSite Not Available
University of Tennessee Methodist Physicians
Memphis, Tennessee 38104
United StatesSite Not Available
Medical City Fort Worth
Fort Worth, Texas 76104
United StatesSite Not Available
University of Texas Health Sciences Center at Houston - Center for Advanced Heart Failure
Houston, Texas 77030
United StatesSite Not Available
Tyler Cardiovascular Consultants
Tyler, Texas 75701
United StatesSite Not Available
University of Virginia Medical Center
Charlottesville, Virginia 22903
United StatesSite Not Available
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United StatesSite Not Available
Swedish Medical Center Cherry Hill
Seattle, Washington 98122
United StatesSite Not Available
Saint Joseph Medical Center (Tacoma WA)
Tacoma, Washington 98405
United StatesSite Not Available
Charleston Area Medical Center (CAMC) Memorial Hospital
Charleston, West Virginia 25304
United StatesSite Not Available
West Virginia University
Morgantown, West Virginia 26506
United StatesSite Not Available
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