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Heart monitor study aims to predict heart failure Flare-Ups

NCT ID NCT04790344

Knowledge-focused Sponsor: Boston Scientific Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 6 times

Summary

This study is testing an implantable heart monitor (LUX-Dx ICM) in 525 people with heart failure. The goal is to collect sensor data to better understand when heart failure events happen. Participants have moderate heart failure (NYHA class II or III) and certain heart structure changes. The study does not test a treatment, only gathers information.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LUX-Dx insertable cardiac monitor (device)
What this could lead to
If successful, this could help doctors better predict and manage heart failure events using sensor data from an implanted monitor.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to any direct benefit for participants or change in clinical practice.

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

557 people

The number who actually took part.

Started

Mar 2021

Finished

Jul 2026

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.

Key Inclusion Criteria: * Patient is currently in NYHA Class II or III. * For patients with LVEF \>40% measured on most recent available echocardiography within the previous 12 months: * ONE (1) of the following echocardiography findings: LA width (diameter) \>3.8 cm, LA length \>5.0 cm, LA area \>20 cm2, LA volume \>55 ml, LA volume index \>29 ml/m2, LVH defined by septal thickness or posterior wall thickness of \>1.1 cm AND * ONE (1) of the following: Elevated BNP/NT-proBNP as defined by: BNP \>100 pg/ml or NT-proBNP \>300 pg/ml within the previous 90 days for patients not in atrial fibrillation or BNP \>300 pg/ml or NT-proBNP \>900 pg/ml for patients in atrial fibrillation at the time of screening for eligibility OR Documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months * For patients with LVEF \<40% (for MI patients, measured no less than 30 days post-MI) on most recent available echocardiography within the previous 12 months: * ONE (1) of the following: Elevated BNP/NT-proBNP as defined by BNP \>150 pg/ml or NT-proBNP \>600 pg/ml within the previous 90 days for patients not in atrial fibrillation or BNP \>450 pg/ml or NT-proBNP \>1800 pg/ml for patients in atrial fibrillation at the time of screening for eligibility OR Documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months * Patient is willing to be monitored in LATITUDE Clarity and use the ICM patient mobile app. * Patient is of legal age to give informed consent and is willing to participate in the trial. Key Exclusion Criteria: * Patient is currently implanted with any other active electronic medical device. * Patient has undergone a heart transplant. * Patient is currently enrolled in another investigational study (excluding registries) without prior written approval from Boston Scientific. * Patient is known to be pregnant at the time of enrollment or plans to become pregnant during study participation. * Patient is diagnosed with amyloidosis or hypertrophic cardiomyopathy.

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

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

Heart failure

Contacts and locations

Locations

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515, United States

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401, United States

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Capital Cardiology Associates, PC

    Albany, New York, 12211, United States

  • Cardiology Associates Medical Group

    Ventura, California, 55109, United States

  • Cardiology Associates Research, LLC/North Mississippi Medical Center

    Tupelo, Mississippi, 38801, United States

  • Cardiovascular Associates of the Delaware Valley

    Sewell, New Jersey, 08080, United States

  • Cardiovascular Research of Knoxville

    Powell, Tennessee, 37849, United States

  • Columbia University Medical Center/NYPH

    New York, New York, 10032, United States

  • Community Heart and Vascular Hospital

    Indianapolis, Indiana, 46250, United States

  • Franciscan Physician Network-Indiana Heart Physicians

    Indianapolis, Indiana, 46237, United States

  • Grandview Medical Center - Affinity Hospital, LLC

    Birmingham, Alabama, 35243, United States

  • John Muir Medical Center

    Concord, California, 94520, United States

  • Kaiser Permanenty Los Angeles Medical Center

    Los Angeles, California, 90027, United States

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103, United States

  • M Health Fairview St. John's Hospital

    Maplewood, Minnesota, 55109, United States

  • Marshall Cardiology

    Huntington, West Virginia, 25701, United States

  • Medication Management

    Greensboro, North Carolina, 27408, United States

  • Minneapolis VA

    Minneapolis, Minnesota, 55417, United States

  • Mobile Infirmary

    Mobile, Alabama, 36608, United States

  • Naples Heart and Rhythm

    Naples, Florida, 34119, United States

  • New York Methodist Hospital

    Brooklyn, New York, 11215, United States

  • North Florida South Georgia VA

    Gainesville, Florida, 32608, United States

  • Northeast Georgia Heart Center, Inc.

    Gainesville, Georgia, 30501, United States

  • Northside Hospital

    Gainesville, Georgia, 30342, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Orion Medical

    Pasadena, Texas, 77505, United States

  • PeaceHealth Southwest

    Vancouver, Washington, 98664, United States

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Piedmont Augusta Hospital

    Augusta, Georgia, 30901, United States

  • Providence Sacred Heart Medical Center

    Spokane, Washington, 99204, United States

  • Ralph H. Johnson Department of Veterans Affairs Medical Center

    Charleston, South Carolina, 29401, United States

  • Sacred Heart Medical Center at Riverbend

    Springfield, Oregon, 97477, United States

  • Saint Louis University Hospital

    St Louis, Missouri, 63110, United States

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • San Diego Cardiac Center

    San Diego, California, 92123, United States

  • Sanger Heart and Vascular Institute

    Charlotte, North Carolina, 28204, United States

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239, United States

  • Scripps Memorial Hospital

    La Jolla, California, 92037, United States

  • St. John's Center for Clinical Research (First Coast Heart and Vascular Center, PLLC)

    Jacksonville, Florida, 32216, United States

  • St. Luke's Idaho Cardiology Associates

    Boise, Idaho, 83712, United States

  • St. Thomas Research Institute

    Nashville, Tennessee, 37205, United States

  • The Cardiac and Vascular Institute

    Gainesville, Florida, 32605, United States

  • The New York Hospital Medical Center of Queens

    New York, New York, 11355, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • University of California - Irvine

    Orange, California, 92868, United States

  • University of Kansas Hospital

    Kansas City, Kansas, 66160, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39219, United States

  • University of Pittsburgh Medical Center Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555, United States

  • VA Loma Linda

    Loma Linda, California, 92357, United States

  • VA Puget Sound Healthcare System

    Seattle, Washington, 98108, United States

  • Village Heart and Vein Center

    Lady Lake, Florida, 32159, United States

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157, United States

  • WakeMed

    Raleigh, North Carolina, 27610, United States

  • Wellspan York Hospital

    York, Pennsylvania, 17403, United States

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