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Smart algorithm aims to improve heart failure care

NCT ID NCT04452149

Disease control Sponsor: Medtronic Cardiac Rhythm and Heart Failure Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study tested a new way to manage heart failure using a small heart monitor (Reveal LINQ) and a special algorithm. The goal was to see if this approach could safely guide treatment and improve outcomes for people with moderate heart failure. 826 participants with NYHA class II or III heart failure were enrolled. The study compared the algorithm-guided care to standard care, looking at safety and effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

826 people

The number who actually took part.

Started

Sep 2020

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

heart failure mild heart failure moderate heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure nyha class II Heart failure nyha class III

Contacts and locations

Locations

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72410, United States

  • Ascension Medical Group - Saint Vincent

    Indianapolis, Indiana, 46260, United States

  • Baptist Health

    Jacksonville, Florida, 32207, United States

  • Baptist Healthcare System

    Louisville, Kentucky, 40207, United States

  • Baptist Hospital

    Pensacola, Florida, 32501, United States

  • Bay Area Cardiology Associates PA

    Brandon, Florida, 33511, United States

  • CHI Health Creighton University Medical Center - Bergan Mercy

    Omaha, Nebraska, 68124, United States

  • Cardiology Associates Medical Group

    Oxnard, California, 93030, United States

  • Cardiology Associates of North Mississippi

    Tupelo, Mississippi, 38801, United States

  • Cardiology Consultants of Philadelphia

    Philadelphia, Pennsylvania, 19107, United States

  • Cardiovascular Associates of Mesa

    Mesa, Arizona, 85282, United States

  • Carle Foundation Hospital

    Urbana, Illinois, 61801, United States

  • Charleston Area Medical Center (CAMC) Memorial Hospital

    Charleston, West Virginia, 25304, United States

  • Citrus Cardiology Consultants PA

    Leesburg, Florida, 34748, United States

  • Columbia University Irving Medical Center/NYPH

    New York, New York, 10032, United States

  • Cone Health

    Greensboro, North Carolina, 27401, United States

  • Doylestown Health Cardiology a division of Doylestown Health Physicians

    Doylestown, Pennsylvania, 18901, United States

  • FWD Clinical Research LLC

    Boca Raton, Florida, 33486, United States

  • First Coast Cardiovascular Institute PA

    Jacksonville, Florida, 32256, United States

  • Florida Heart Center

    Ft. Pierce, Florida, 34950, United States

  • Hudson Valley Heart Center

    Poughkeepsie, New York, 12601, United States

  • Iowa Heart Center

    West Des Moines, Iowa, 50266, United States

  • Lourdes Cardiology Services

    Voorhees Township, New Jersey, 08043, United States

  • Medical City Fort Worth

    Fort Worth, Texas, 76104, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404, United States

  • Mount Carmel East

    Columbus, Ohio, 43213, United States

  • New Mexico Heart Institute PA

    Albuquerque, New Mexico, 87102, United States

  • North Memorial Health Heart &amp; Vascular Center

    Robbinsdale, Minnesota, 55422, United States

  • NorthShore University Health System

    Evanston, Illinois, 60201, United States

  • Northside Hospital

    St. Petersburg, Florida, 33709, United States

  • Norton Healthcare

    Louisville, Kentucky, 40217, United States

  • Novant Health New Hanover Regional Medical Center

    Wilmington, North Carolina, 28401, United States

  • OhioHealth Research and Innovation Institute (OHRI)

    Columbus, Ohio, 43214, United States

  • Parkview Health

    Fort Wayne, Indiana, 46845, United States

  • Prisma Health Midlands

    Columbia, South Carolina, 29203, United States

  • Saint Elizabeth Healthcare

    Edgewood, Kentucky, 41017, United States

  • Saint Francis Hospital

    Roslyn, New York, 11576, United States

  • Saint Joseph Heritage Healthcare

    Mission Viejo, California, 92691, United States

  • Saint Joseph Medical Center (Tacoma WA)

    Tacoma, Washington, 98405, United States

  • Saint Joseph's Medical Center

    Stockton, California, 95204, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • South Denver Cardiology Associates

    Littleton, Colorado, 80120, United States

  • Stony Brook University Hospital

    Stony Brook, New York, 11794, United States

  • Swedish Medical Center Cherry Hill

    Seattle, Washington, 98122, United States

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308, United States

  • The Lindner Research Center

    Cincinnati, Ohio, 45219, United States

  • The Stern Cardiovascular Foundation

    Germantown, Tennessee, 38138, United States

  • Tyler Cardiovascular Consultants

    Tyler, Texas, 75701, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of Tennessee Methodist Physicians

    Memphis, Tennessee, 38104, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.