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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: Investigational LUX-Dx ICM Implant

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 525
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center - Affinity Hospital, LLC
    • Mobile, Alabama, United States, 36608
      • Mobile Infirmary
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Arrhythmia Research Group
  • California
    • Concord, California, United States, 94520
      • John Muir Medical Center
    • La Jolla, California, United States, 92037
      • Scripps Memorial Hospital
    • Loma Linda, California, United States, 92357
      • VA Loma Linda
    • Los Angeles, California, United States, 90027
      • Kaiser Permanenty Los Angeles Medical Center
    • Orange, California, United States, 92868
      • University of California - Irvine
    • San Diego, California, United States, 92123
      • San Diego Cardiac Center
    • Ventura, California, United States, 55109
      • Cardiology Associates Medical Group
  • Florida
    • Gainesville, Florida, United States, 32605
      • The Cardiac and Vascular Institute
    • Gainesville, Florida, United States, 32608
      • North Florida South Georgia VA
    • Jacksonville, Florida, United States, 32216
      • St. John's Center for Clinical Research (First Coast Heart and Vascular Center, PLLC)
    • Lady Lake, Florida, United States, 32159
      • Village Heart and Vein Center
    • Naples, Florida, United States, 34119
      • Naples Heart and Rhythm
    • Orlando, Florida, United States, 32806
      • Orlando Regional Medical Center
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University
    • Augusta, Georgia, United States, 30901
      • Piedmont Augusta Hospital
    • Gainesville, Georgia, United States, 30342
      • Northside Hospital
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Heart Center, Inc.
  • Idaho
    • Boise, Idaho, United States, 83712
      • St. Luke's Idaho Cardiology Associates
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Downers Grove, Illinois, United States, 60515
      • Advocate Good Samaritan Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Community Heart and Vascular Hospital
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Physician Network-Indiana Heart Physicians
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Heart and Vascular Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Minnesota
    • Maplewood, Minnesota, United States, 55109
      • M Health Fairview St. John's Hospital
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis VA
  • Mississippi
    • Jackson, Mississippi, United States, 39219
      • University of Mississippi Medical Center
    • Tupelo, Mississippi, United States, 38801
      • Cardiology Associates Research, LLC/North Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
    • Saint Louis, Missouri, United States, 63110
      • Saint Louis University Hospital
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • New Jersey Medical School, University of Medicine & Dentistry of New Jersey
    • Sewell, New Jersey, United States, 08080
      • Cardiovascular Associates of the Delaware Valley
  • New York
    • Albany, New York, United States, 12211
      • Capital Cardiology Associates, PC
    • Brooklyn, New York, United States, 11215
      • New York Methodist Hospital
    • New York, New York, United States, 10032
      • Columbia University Medical Center/NYPH
    • New York, New York, United States, 11355
      • The New York Hospital Medical Center of Queens
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Sanger Heart and Vascular Institute
    • Greensboro, North Carolina, United States, 27408
      • Medication Management
    • Raleigh, North Carolina, United States, 27610
      • WakeMed
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Sacred Heart Medical Center at Riverbend
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center Presbyterian Hospital
    • York, Pennsylvania, United States, 17403
      • WellSpan York Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Ralph H. Johnson Department of Veterans Affairs Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37205
      • St. Thomas Research Institute
    • Powell, Tennessee, United States, 37849
      • Cardiovascular Research of Knoxville
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
    • Pasadena, Texas, United States, 77505
      • Orion Medical
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound Healthcare System
    • Vancouver, Washington, United States, 98664
      • PeaceHealth Southwest
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Marshall Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; All study subjects belong to Treatment Arm, which is receiving investigational LUX-Dx ICM device.	Device: Investigational LUX-Dx ICM Implant; All subject will receive an investigational version of the LUX-Dx ICM device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Scott Solomon, MD, Brigham and Women's Hospital; Principal Investigator: Elaine Wan, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2021
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: C2118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No