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LUX-Dx TRENDS evaluerer diagnostiske sensorer i hjertesvigtspatienter, der modtager Boston Scientifics undersøgelses ICM-system.

2. oktober 2026 opdateret af: Boston Scientific Corporation

LUX-Dx hjertesvigtssensorer i et indsætteligt hjertemonitorsystem klinisk undersøgelse (LUX-Dx TRENDS)

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

557

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35243
        • Grandview Medical Center - Affinity Hospital, LLC
      • Mobile, Alabama, Forenede Stater, 36608
        • Mobile Infirmary
    • Arkansas
      • Jonesboro, Arkansas, Forenede Stater, 72401
        • Arrhythmia Research Group
    • California
      • Concord, California, Forenede Stater, 94520
        • John Muir Medical Center
      • La Jolla, California, Forenede Stater, 92037
        • Scripps Memorial Hospital
      • Loma Linda, California, Forenede Stater, 92357
        • VA Loma Linda
      • Los Angeles, California, Forenede Stater, 90027
        • Kaiser Permanenty Los Angeles Medical Center
      • Orange, California, Forenede Stater, 92868
        • University of California - Irvine
      • San Diego, California, Forenede Stater, 92123
        • San Diego Cardiac Center
      • Ventura, California, Forenede Stater, 55109
        • Cardiology Associates Medical Group
    • Florida
      • Gainesville, Florida, Forenede Stater, 32605
        • The Cardiac and Vascular Institute
      • Gainesville, Florida, Forenede Stater, 32608
        • North Florida South Georgia VA
      • Jacksonville, Florida, Forenede Stater, 32216
        • St. John's Center for Clinical Research (First Coast Heart and Vascular Center, PLLC)
      • Lady Lake, Florida, Forenede Stater, 32159
        • Village Heart and Vein Center
      • Naples, Florida, Forenede Stater, 34119
        • Naples Heart and Rhythm
      • Sarasota, Florida, Forenede Stater, 34239
        • Sarasota Memorial Hospital
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912
        • Augusta University
      • Augusta, Georgia, Forenede Stater, 30901
        • Piedmont Augusta Hospital
      • Gainesville, Georgia, Forenede Stater, 30342
        • Northside Hospital
      • Gainesville, Georgia, Forenede Stater, 30501
        • Northeast Georgia Heart Center, Inc.
    • Idaho
      • Boise, Idaho, Forenede Stater, 83712
        • St. Luke's Idaho Cardiology Associates
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University
      • Downers Grove, Illinois, Forenede Stater, 60515
        • Advocate Good Samaritan Hospital
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46250
        • Community Heart and Vascular Hospital
      • Indianapolis, Indiana, Forenede Stater, 46237
        • Franciscan Physician Network-Indiana Heart Physicians
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • University of Kansas Hospital
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40503
        • Baptist Health Lexington
    • Minnesota
      • Maplewood, Minnesota, Forenede Stater, 55109
        • M Health Fairview St. John's Hospital
      • Minneapolis, Minnesota, Forenede Stater, 55417
        • Minneapolis VA
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39219
        • University of Mississippi Medical Center
      • Tupelo, Mississippi, Forenede Stater, 38801
        • Cardiology Associates Research, LLC/North Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • Saint Luke's Hospital of Kansas City
      • St Louis, Missouri, Forenede Stater, 63110
        • Saint Louis University Hospital
    • New Jersey
      • Sewell, New Jersey, Forenede Stater, 08080
        • Cardiovascular Associates of the Delaware Valley
    • New York
      • Albany, New York, Forenede Stater, 12211
        • Capital Cardiology Associates, PC
      • Brooklyn, New York, Forenede Stater, 11215
        • New York Methodist Hospital
      • New York, New York, Forenede Stater, 10032
        • Columbia University Medical Center/NYPH
      • New York, New York, Forenede Stater, 11355
        • The New York Hospital Medical Center of Queens
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Sanger Heart and Vascular Institute
      • Greensboro, North Carolina, Forenede Stater, 27408
        • Medication Management
      • Raleigh, North Carolina, Forenede Stater, 27610
        • WakeMed
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University School of Medicine
    • Oregon
      • Springfield, Oregon, Forenede Stater, 97477
        • Sacred Heart Medical Center at Riverbend
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • Lehigh Valley Hospital
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Penn State Health Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh Medical Center Presbyterian Hospital
      • York, Pennsylvania, Forenede Stater, 17403
        • Wellspan York Hospital
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29401
        • Ralph H. Johnson Department of Veterans Affairs Medical Center
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37205
        • St. Thomas Research Institute
      • Powell, Tennessee, Forenede Stater, 37849
        • Cardiovascular Research of Knoxville
    • Texas
      • Galveston, Texas, Forenede Stater, 77555
        • University of Texas Medical Branch
      • Pasadena, Texas, Forenede Stater, 77505
        • Orion Medical
    • Washington
      • Seattle, Washington, Forenede Stater, 98108
        • VA Puget Sound Healthcare System
      • Spokane, Washington, Forenede Stater, 99204
        • Providence Sacred Heart Medical Center
      • Vancouver, Washington, Forenede Stater, 98664
        • PeaceHealth Southwest
    • West Virginia
      • Huntington, West Virginia, Forenede Stater, 25701
        • Marshall Cardiology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment Arm

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

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

Hvad måler undersøgelsen?

Primære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boston Scientific Corporation

Efterforskere

  • Ledende efterforsker: Scott Solomon, MD, Brigham and Women's Hospital
  • Ledende efterforsker: Elaine Wan, MD, Columbia University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. marts 2021

Primær færdiggørelse (Faktiske)

27. juli 2026

Studieafslutning (Faktiske)

27. juli 2026

Datoer for studieregistrering

Først indsendt

4. marts 2021

Først indsendt, der opfyldte QC-kriterier

5. marts 2021

Først opslået (Faktiske)

10. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C2118

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner