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ACTIVE NOT RECRUITING

NCT04790344

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

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

Summary

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

Official title: LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study (LUX-Dx TRENDS)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

525

Start Date

2021-03-20

Completion Date

2026-06

Last Updated

2026-03-17

Healthy Volunteers

Conditions

Heart Failure

Interventions

DEVICE

Investigational LUX-Dx ICM Implant

All subject will receive an investigational version of the LUX-Dx ICM device.

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.

Locations (56)

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