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

NCT04790344 | Active Not Recruiting FDA Device

• 1 other identifier: C2118
• Study Type: interventional
• Target: 525
• Locations: 1 country
• Sites: 56

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC.

  Heart Failure (HF) event is defined as: * HF Hospitalization: subject is admitted with a calendar date change with signs/symptoms of congestive heart failure (CHF) and receives unscheduled augmented HF therapy with oral or intravenous medications, ultrafiltration therapy or other parenteral therapy. * HF Outpatient Visit: subject has signs/symptoms of CHF, and receives unscheduled intravenous decongestive therapy in a setting that does not involve a hospitalization with a calendar date change (e.g.: ER visit, HF clinic, primary care clinic, etc.).

  Through study completion of approximately 4.5 year

Study Arms (1)

Treatment Arm

EXPERIMENTAL

All study subjects belong to Treatment Arm, which is receiving investigational LUX-Dx ICM device.

Device: Investigational LUX-Dx ICM Implant

Interventions

Investigational LUX-Dx ICM Implant DEVICE

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

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (56)

Grandview Medical Center - Affinity Hospital, LLC

Birmingham, Alabama, 35243, United States

Location

Mobile Infirmary

Mobile, Alabama, 36608, United States

Location

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

John Muir Medical Center

Concord, California, 94520, United States

Location

Scripps Memorial Hospital

La Jolla, California, 92037, United States

Location

VA Loma Linda

Loma Linda, California, 92357, United States

Location

Kaiser Permanenty Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

University of California - Irvine

Orange, California, 92868, United States

Location

San Diego Cardiac Center

San Diego, California, 92123, United States

Location

Cardiology Associates Medical Group

Ventura, California, 55109, United States

Location

The Cardiac and Vascular Institute

Gainesville, Florida, 32605, United States

Location

North Florida South Georgia VA

Gainesville, Florida, 32608, United States

Location

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

Jacksonville, Florida, 32216, United States

Location

Village Heart and Vein Center

Lady Lake, Florida, 32159, United States

Location

Naples Heart and Rhythm

Naples, Florida, 34119, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Piedmont Augusta Hospital

Augusta, Georgia, 30901, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Northside Hospital

Gainesville, Georgia, 30342, United States

Location

Northeast Georgia Heart Center, Inc.

Gainesville, Georgia, 30501, United States

Location

St. Luke's Idaho Cardiology Associates

Boise, Idaho, 83712, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515, United States

Location

Franciscan Physician Network-Indiana Heart Physicians

Indianapolis, Indiana, 46237, United States

Location

Community Heart and Vascular Hospital

Indianapolis, Indiana, 46250, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

M Health Fairview St. John's Hospital

Maplewood, Minnesota, 55109, United States

Location

Minneapolis VA

Minneapolis, Minnesota, 55417, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39219, United States

Location

Cardiology Associates Research, LLC/North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Saint Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Cardiovascular Associates of the Delaware Valley

Sewell, New Jersey, 08080, United States

Location

Capital Cardiology Associates, PC

Albany, New York, 12211, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

The New York Hospital Medical Center of Queens

New York, New York, 11355, United States

Location

Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28204, United States

Location

Medication Management

Greensboro, North Carolina, 27408, United States

Location

WakeMed

Raleigh, North Carolina, 27610, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Sacred Heart Medical Center at Riverbend

Springfield, Oregon, 97477, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Wellspan York Hospital

York, Pennsylvania, 17403, United States

Location

Ralph H. Johnson Department of Veterans Affairs Medical Center

Charleston, South Carolina, 29401, United States

Location

St. Thomas Research Institute

Nashville, Tennessee, 37205, United States

Location

Cardiovascular Research of Knoxville

Powell, Tennessee, 37849, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Orion Medical

Pasadena, Texas, 77505, United States

Location

VA Puget Sound Healthcare System

Seattle, Washington, 98108, United States

Location

PeaceHealth Southwest

Vancouver, Washington, 98664, United States

Location

Marshall Cardiology

Huntington, West Virginia, 25701, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Scott Solomon, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Elaine Wan, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Physiologic Sensor data will be blinded to participants and care providers. LUX-Dx ICM commercial features will be Open Label.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 10, 2021
• Study Start: March 20, 2021
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (56)