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

September 1, 2026 updated by: Boston Scientific Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
557

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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
      • 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
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
    • 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
      • St Louis, Missouri, United States, 63110
        • Saint Louis University Hospital
    • 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, 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
      • Spokane, Washington, United States, 99204
        • Providence Sacred Heart Medical Center
      • Vancouver, Washington, United States, 98664
        • PeaceHealth Southwest
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Marshall Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: Through study completion of approximately 4.5 year

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Scott Solomon, MD, Brigham and Women's Hospital
  • Principal Investigator: Elaine Wan, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings