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 LINQâ„¢ system and procedure in the study population.

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Heart Failure

Estimated Enrollment:

700

Study ID:

NCT04452149

Recruitment Status:

Recruiting

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

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There are 58 Locations for this study

See Locations Near You

Cardiovascular Associates of Mesa
Mesa Arizona, 85282, United States
Arrhythmia Research Group
Jonesboro Arkansas, 72410, United States More Info
Devi Nair, M.D.
Contact
Saint Joseph Heritage Healthcare
Mission Viejo California, 92691, United States
Cardiology Associates Medical Group
Oxnard California, 93030, United States More Info
Jonathan Dukes, M.D.
Contact
Saint Joseph's Medical Center
Stockton California, 95204, United States More Info
Cyrus Buhari, M.D.
Contact
South Denver Cardiology Associates
Littleton Colorado, 80120, United States More Info
Ira Dauber, M.D.
Contact
FWD Clinical Research LLC
Boca Raton Florida, 33486, United States More Info
Michael Cammarata, M.D.
Contact
Bay Area Cardiology Associates PA
Brandon Florida, 33511, United States More Info
Stephen Mester, M.D.
Contact
Florida Heart Center
Fort Pierce Florida, 34950, United States More Info
Prasad Chalasani, M.D.
Contact
Baptist Health
Jacksonville Florida, 32207, United States More Info
Ruple Galani, MD
Contact
First Coast Cardiovascular Institute PA
Jacksonville Florida, 32256, United States More Info
Sumant Lamba, M.D.
Contact
Citrus Cardiology Consultants PA
Leesburg Florida, 34748, United States More Info
Hector Garcia, M.D.
Contact
Baptist Hospital
Pensacola Florida, 32501, United States More Info
Sumit Verma, M.D.
Contact
Northside Hospital
Saint Petersburg Florida, 33709, United States More Info
Robert Sanchez, M.D.
Contact
Tallahassee Research Institute
Tallahassee Florida, 32308, United States More Info
Gian-Carlo Giove, M.D.
Contact
Memorial Health University Medical Center
Savannah Georgia, 31404, United States More Info
David Newton, M.D.
Contact
NorthShore University Health System
Evanston Illinois, 60201, United States More Info
Mark Metzl, M.D.
Contact
Carle Foundation Hospital
Urbana Illinois, 61801, United States
Parkview Health
Fort Wayne Indiana, 46845, United States More Info
Patrick Gregory, M.D.
Contact
Ascension Medical Group - Saint Vincent
Indianapolis Indiana, 46260, United States More Info
Sunit-Preet Chaudhry, M.D.
Contact
Iowa Heart Center
West Des Moines Iowa, 50266, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States More Info
Madhu Reddy, M.D.
Contact
Saint Elizabeth Healthcare
Edgewood Kentucky, 41017, United States More Info
Hareeprasad Vongooru, M.D.
Contact
Baptist Healthcare System
Louisville Kentucky, 40207, United States More Info
Steven Heatherly, M.D.
Contact
Norton Healthcare
Louisville Kentucky, 40217, United States More Info
Srikanth Seethala, M.D.
Contact
Advanced Cardiovascular Specialists
Shreveport Louisiana, 71105, United States
North Memorial Health Heart & Vascular Center
Robbinsdale Minnesota, 55422, United States More Info
Chike Obi, M.D.
Contact
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States More Info
Robert Craig Long, M.D.
Contact
Cardiology Associates of North Mississippi
Tupelo Mississippi, 38801, United States More Info
Barry Bertolet, M.D.
Contact
Missouri Cardiovascular Specialists
Columbia Missouri, 65201, United States
CHI Health Nebraska Heart
Lincoln Nebraska, 68526, United States
CHI Health Creighton University Medical Center - Bergan Mercy
Omaha Nebraska, 68124, United States More Info
Selma Mohammed, M.D.
Contact
Lourdes Cardiology Services
Voorhees New Jersey, 08043, United States More Info
Darius Sholevar, M.D.
Contact
New Mexico Heart Institute PA
Albuquerque New Mexico, 87102, United States More Info
Eddie Brown, D.O.
Contact
New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn New York, 11215, United States More Info
Bharath Reddy, M.D.
Contact
Columbia University Irving Medical Center/NYPH
New York New York, 10032, United States More Info
Kelly Axsom, M.D.
Contact
Hudson Valley Heart Center
Poughkeepsie New York, 12601, United States More Info
James Lyons, M.D.
Contact
Saint Francis Hospital
Roslyn New York, 11576, United States More Info
Rita Jermyn, M.D.
Contact
Stony Brook University Hospital
Stony Brook New York, 11794, United States More Info
Hal Skopicki, M.D.
Contact
Cone Health
Greensboro North Carolina, 27401, United States More Info
Cameron Lambert, M.D.
Contact
Novant Health New Hanover Regional Medical Center
Wilmington North Carolina, 28401, United States More Info
John Rommel, M.D.
Contact
The Lindner Research Center
Cincinnati Ohio, 45219, United States More Info
Ankit Bhatia, M.D.
Contact
Mount Carmel East
Columbus Ohio, 43213, United States More Info
Laura Gravelin, M.D.
Contact
OhioHealth Research and Innovation Institute (OHRI)
Columbus Ohio, 43214, United States More Info
Anup Basuray, M.D.
Contact
Doylestown Health Cardiology a division of Doylestown Health Physicians
Doylestown Pennsylvania, 18901, United States More Info
Renee Sangrigoli, M.D.
Contact
Cardiology Consultants of Philadelphia
Philadelphia Pennsylvania, 19107, United States More Info
Matthew Goldstein, M.D.
Contact
Medical University of South Carolina
Charleston South Carolina, 29425, United States More Info
Gregory Jackson, M.D.
Contact
Prisma Health Midlands
Columbia South Carolina, 29203, United States More Info
W. Robert Mazzei, M.D.
Contact
The Stern Cardiovascular Foundation
Germantown Tennessee, 38138, United States More Info
Frank McGrew, M.D.
Contact
University of Tennessee Methodist Physicians
Memphis Tennessee, 38104, United States More Info
Isaac Rhea, M.D.
Contact
Medical City Fort Worth
Fort Worth Texas, 76104, United States More Info
Amir Malik, M.D.
Contact
Tyler Cardiovascular Consultants
Tyler Texas, 75701, United States More Info
Raul Torres, M.D.
Contact
University of Virginia Medical Center
Charlottesville Virginia, 22903, United States
Sentara Norfolk General Hospital
Norfolk Virginia, 23507, United States More Info
Erich Kiehl, M.D.
Contact
Swedish Medical Center Cherry Hill
Seattle Washington, 98122, United States More Info
John Mignone, M.D.
Contact
Saint Joseph Medical Center (Tacoma WA)
Tacoma Washington, 98405, United States More Info
David Zhang, M.D.
Contact
Charleston Area Medical Center (CAMC) Memorial Hospital
Charleston West Virginia, 25304, United States More Info
Elie Gharib, M.D.
Contact
West Virginia University
Morgantown West Virginia, 26506, United States More Info
George Sokos, M.D.
Contact

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

700

Study ID:

NCT04452149

Recruitment Status:

Recruiting

Sponsor:


Medtronic Cardiac Rhythm and Heart Failure

How clear is this clinincal trial information?

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