LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.

Last updated: April 7, 2025
Sponsor: Boston Scientific Corporation
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Heart Failure

Congestive Heart Failure

Chest Pain

Treatment

Investigational LUX-Dx ICM Implant

Clinical Study ID

NCT04790344
C2118
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to collect sensor data from insertable cardiac monitor systems.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Patient is currently in NYHA Class II or III.

  • For patients with LVEF >40% measured on most recent available echocardiographywithin the previous 12 months:

  • ONE (1) of the following echocardiography findings: LA width (diameter) >3.8cm, LA length >5.0 cm, LA area >20 cm2, LA volume >55 ml, LA volume index >29ml/m2, LVH defined by septal thickness or posterior wall thickness of >1.1 cmAND

  • ONE (1) of the following: Elevated BNP/NT-proBNP as defined by: BNP >100 pg/mlor NT-proBNP >300 pg/ml within the previous 90 days for patients not in atrialfibrillation or BNP >300 pg/ml or NT-proBNP >900 pg/ml for patients in atrialfibrillation at the time of screening for eligibility OR Documented heartfailure 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/mlor NT-proBNP >600 pg/ml within the previous 90 days for patients not in atrialfibrillation or BNP >450 pg/ml or NT-proBNP >1800 pg/ml for patients in atrialfibrillation at the time of screening for eligibility OR Documented heartfailure 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 patientmobile app.

  • Patient is of legal age to give informed consent and is willing to participate inthe trial.

Exclusion

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 (excludingregistries) without prior written approval from Boston Scientific.

  • Patient is known to be pregnant at the time of enrollment or plans to becomepregnant during study participation.

  • Patient is diagnosed with amyloidosis or hypertrophic cardiomyopathy.

Study Design

Total Participants: 525
Treatment Group(s): 1
Primary Treatment: Investigational LUX-Dx ICM Implant
Phase:
Study Start date:
March 20, 2021
Estimated Completion Date:
June 30, 2026

Study Description

The primary objective of this study is to collect physiological measurement data and heart failure (HF) event data that will be used to design and develop new diagnostic features for the insertable cardiac monitor (ICM) systems. This study will not have pre-defined statistical endpoints. To support the primary objective, diagnostic sensor data will be compared to reference clinical testing data and heart failure decompensation events.

Connect with a study center

  • Grandview Medical Center - Affinity Hospital, LLC

    Birmingham, Alabama 35243
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Mobile Infirmary

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Southwest Cardiovascular Associates

    Mesa, Arizona 85208
    United States

    Site Not Available

  • Arrhythmia Research Group

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • John Muir Medical Center

    Concord, California 94520
    United States

    Site Not Available

  • Scripps Memorial Hospital

    La Jolla, California 92037
    United States

    Site Not Available

  • VA Loma Linda

    Loma Linda, California 92357
    United States

    Site Not Available

  • Kaiser Permanenty Los Angeles Medical Center

    Los Angeles, California 90027
    United States

    Site Not Available

  • University of Southern California Hospital

    Los Angeles, California 90033
    United States

    Site Not Available

  • University of California - Irvine

    Orange, California 92868
    United States

    Site Not Available

  • San Diego Cardiac Center

    San Diego, California 92123
    United States

    Site Not Available

  • Cardiology Associates Medical Group

    Ventura, California 55109
    United States

    Site Not Available

  • University of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Memorial Hospital

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Holy Cross

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • North Florida South Georgia VA

    Gainesville, Florida 32608
    United States

    Site Not Available

  • The Cardiac and Vascular Institute

    Gainesville, Florida 32605
    United States

    Site Not Available

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

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • University of Florida Health - Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Village Heart and Vein Center

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • Naples Heart and Rhythm

    Naples, Florida 34119
    United States

    Site Not Available

  • Orlando Regional Medical Center

    Orlando, Florida 32806
    United States

    Site Not Available

  • Peace River Cardiovascular Center

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Tallahassee Research Institute

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Advent Health - Tampa

    Tampa, Florida 33613
    United States

    Site Not Available

  • Augusta University

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Piedmont Augusta Hospital

    Augusta, Georgia 30901
    United States

    Site Not Available

  • University Hospital

    Augusta, Georgia 30901
    United States

    Active - Recruiting

  • Northeast Georgia Heart Center, Inc.

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Northside Hospital

    Gainesville, Georgia 30342
    United States

    Site Not Available

  • Coliseum Medical Center

    Macon, Georgia 31201
    United States

    Site Not Available

  • Queen's Medical Center

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • St. Luke's Idaho Cardiology Associates

    Boise, Idaho 83712
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • The University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois 60515
    United States

    Site Not Available

  • Community Heart and Vascular Hospital

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Franciscan Physician Network-Indiana Heart Physicians

    Indianapolis, Indiana 46237
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Kansas Hospital

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Baptist Health East Louisville

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • Willis Knighton Bossier Medical Center (Grace Research, LLC)

    Bossier City, Louisiana 71111
    United States

    Site Not Available

  • Tulane University Heart and Vascular Institute

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Spectrum Health Hospital

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • M Health Fairview St. John's Hospital

    Maplewood, Minnesota 55109
    United States

    Site Not Available

  • Minneapolis VA

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39219
    United States

    Site Not Available

  • Cardiology Associates Research, LLC/North Mississippi Medical Center

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Saint Louis University Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Saint Louis University Hospital

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Dartmouth Hitchock Medical Center

    Lebanon, New Hampshire 03766
    United States

    Site Not Available

  • New Jersey Medical School, University of Medicine & Dentistry of New Jersey

    Newark, New Jersey 07103
    United States

    Site Not Available

  • Cardiovascular Associates of Delaware Valley

    Sewell, New Jersey 08080
    United States

    Site Not Available

  • Cardiovascular Associates of the Delaware Valley

    Sewell, New Jersey 08080
    United States

    Site Not Available

  • Capital Cardiology Associates, PC

    Albany, New York 12211
    United States

    Site Not Available

  • New York Methodist Hospital

    Brooklyn, New York 11215
    United States

    Site Not Available

  • Columbia University Medical Center/NYPH

    New York, New York 10032
    United States

    Site Not Available

  • The New York Hospital Medical Center of Queens

    New York, New York 11355
    United States

    Site Not Available

  • Sanger Heart and Vascular Institute

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Medication Management

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • ECU Health Medical Center/Pitt County Memorial Hospital

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • WakeMed

    Raleigh, North Carolina 27610
    United States

    Site Not Available

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • The Ohio State University Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Sacred Heart Medical Center at Riverbend

    Springfield, Oregon 97477
    United States

    Site Not Available

  • Lehigh Valley Hospital

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pittsburgh Medical Center Presbyterian Hospital

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Wellspan York Hospital

    York, Pennsylvania 17403
    United States

    Site Not Available

  • Ralph H. Johnson Department of Veterans Affairs Medical Center

    Charleston, South Carolina 29401
    United States

    Site Not Available

  • Prisma Health - Upstate

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Erlanger Medical Center

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • St. Thomas Research Institute

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Cardiovascular Research of Knoxville

    Powell, Tennessee 37849
    United States

    Site Not Available

  • University of Texas Medical Branch

    Galveston, Texas 77555
    United States

    Site Not Available

  • Orion Medical

    Pasadena, Texas 77505
    United States

    Site Not Available

  • University of Utah Health

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • VA Puget Sound Healthcare System

    Seattle, Washington 98108
    United States

    Site Not Available

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Site Not Available

  • Providence Sacred Heart Medical Center

    Spokane, Washington 99204
    United States

    Site Not Available

  • PeaceHealth Southwest

    Vancouver, Washington 98664
    United States

    Site Not Available

  • Marshall Cardiology

    Huntington, West Virginia 25701
    United States

    Site Not Available

  • Mayo Clinic - La Crossee

    La Crosse, Wisconsin 54601
    United States

    Site Not Available

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