LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
NCT ID: NCT04790344
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
525 participants
INTERVENTIONAL
2021-03-20
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Treatment Arm
All study subjects belong to Treatment Arm, which is receiving investigational LUX-Dx ICM device.
Investigational LUX-Dx ICM Implant
All subject will receive an investigational version of the LUX-Dx ICM device.
Interventions
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Investigational LUX-Dx ICM Implant
All subject will receive an investigational version of the LUX-Dx ICM device.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Solomon, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Elaine Wan, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Grandview Medical Center - Affinity Hospital, LLC
Birmingham, Alabama, United States
Mobile Infirmary
Mobile, Alabama, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
John Muir Medical Center
Concord, California, United States
Scripps Memorial Hospital
La Jolla, California, United States
VA Loma Linda
Loma Linda, California, United States
Kaiser Permanenty Los Angeles Medical Center
Los Angeles, California, United States
University of California - Irvine
Orange, California, United States
San Diego Cardiac Center
San Diego, California, United States
Cardiology Associates Medical Group
Ventura, California, United States
The Cardiac and Vascular Institute
Gainesville, Florida, United States
North Florida South Georgia VA
Gainesville, Florida, United States
St. John's Center for Clinical Research (First Coast Heart and Vascular Center, PLLC)
Jacksonville, Florida, United States
Village Heart and Vein Center
Lady Lake, Florida, United States
Naples Heart and Rhythm
Naples, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Piedmont Augusta Hospital
Augusta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Northside Hospital
Gainesville, Georgia, United States
Northeast Georgia Heart Center, Inc.
Gainesville, Georgia, United States
St. Luke's Idaho Cardiology Associates
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States
Franciscan Physician Network-Indiana Heart Physicians
Indianapolis, Indiana, United States
Community Heart and Vascular Hospital
Indianapolis, Indiana, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
M Health Fairview St. John's Hospital
Maplewood, Minnesota, United States
Minneapolis VA
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Cardiology Associates Research, LLC/North Mississippi Medical Center
Tupelo, Mississippi, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Saint Louis University Hospital
St Louis, Missouri, United States
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, United States
Capital Cardiology Associates, PC
Albany, New York, United States
New York Methodist Hospital
Brooklyn, New York, United States
Columbia University Medical Center/NYPH
New York, New York, United States
The New York Hospital Medical Center of Queens
New York, New York, United States
Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States
Medication Management
Greensboro, North Carolina, United States
WakeMed
Raleigh, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Sacred Heart Medical Center at Riverbend
Springfield, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Wellspan York Hospital
York, Pennsylvania, United States
Ralph H. Johnson Department of Veterans Affairs Medical Center
Charleston, South Carolina, United States
St. Thomas Research Institute
Nashville, Tennessee, United States
Cardiovascular Research of Knoxville
Powell, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
Orion Medical
Pasadena, Texas, United States
VA Puget Sound Healthcare System
Seattle, Washington, United States
PeaceHealth Southwest
Vancouver, Washington, United States
Marshall Cardiology
Huntington, West Virginia, United States
Countries
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Other Identifiers
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C2118
Identifier Type: -
Identifier Source: org_study_id