Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure

Completed · Not applicable

Conditions studied: Heart Failure NYHA Class II, Heart Failure NYHA Class III

In brief

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.

Key facts

Study ID

NCT04452149

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

826

Starts

2020-09-03

Expected to finish

2025-06-02

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Cardiovascular Associates of Mesa — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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