Heart Failure Clinical Trial
Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
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.
Full 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 700 subjects at up to 60 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.
Eligibility Criteria
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.
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There are 59 Locations for this study
Mesa Arizona, 85282, United States More Info
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Jonesboro Arkansas, 72410, United States More Info
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Mission Viejo California, 92691, United States
Oxnard California, 93030, United States More Info
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Stockton California, 95204, United States More Info
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Littleton Colorado, 80120, United States More Info
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Boca Raton Florida, 33486, United States More Info
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Brandon Florida, 33511, United States More Info
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Fort Pierce Florida, 34950, United States More Info
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Jacksonville Florida, 32256, United States More Info
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Leesburg Florida, 34748, United States More Info
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Saint Petersburg Florida, 33709, United States More Info
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Tallahassee Florida, 32308, United States More Info
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Savannah Georgia, 31404, United States More Info
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Evanston Illinois, 60201, United States More Info
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Urbana Illinois, 61801, United States
Indianapolis Indiana, 46260, United States More Info
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West Des Moines Iowa, 50266, United States
Kansas City Kansas, 66160, United States More Info
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Edgewood Kentucky, 41017, United States More Info
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Louisville Kentucky, 40207, United States More Info
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Louisville Kentucky, 40217, United States More Info
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Shreveport Louisiana, 71105, United States
Robbinsdale Minnesota, 55422, United States More Info
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Jackson Mississippi, 39216, United States More Info
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Tupelo Mississippi, 38801, United States More Info
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Columbia Missouri, 65201, United States
Lincoln Nebraska, 68526, United States
Omaha Nebraska, 68124, United States More Info
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Voorhees New Jersey, 08043, United States More Info
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Albuquerque New Mexico, 87102, United States More Info
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Brooklyn New York, 11215, United States More Info
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Mineola New York, 11501, United States More Info
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New York New York, 10032, United States More Info
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Poughkeepsie New York, 12601, United States More Info
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Stony Brook New York, 11794, United States More Info
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Wilmington North Carolina, 28401, United States More Info
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Cincinnati Ohio, 45219, United States More Info
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Columbus Ohio, 43214, United States More Info
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Doylestown Pennsylvania, 18901, United States More Info
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Philadelphia Pennsylvania, 19107, United States More Info
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Charleston South Carolina, 29425, United States More Info
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Columbia South Carolina, 29203, United States More Info
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Germantown Tennessee, 38138, United States More Info
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Memphis Tennessee, 38104, United States
Tyler Texas, 75701, United States More Info
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Charlottesville Virginia, 22903, United States
Norfolk Virginia, 23507, United States More Info
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Seattle Washington, 98122, United States More Info
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Tacoma Washington, 98405, United States More Info
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Charleston West Virginia, 25304, United States More Info
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Morgantown West Virginia, 26506, United States More Info
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