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NCT04452149

Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

826

Start Date

2020-09-03

Completion Date

2025-06-02

Last Updated

2026-08-26

Healthy Volunteers

Conditions

Heart Failure NYHA Class II Heart Failure NYHA Class III

Interventions

DEVICE

Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download

Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download.

OTHER

Medication intervention

Risk status guided medication intervention.

OTHER

Not Randomized to Device or Medication Intervention

No intervention was assigned due to not being randomized under the final version of the investigational plan

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.

Locations (53)

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