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LUX-Dx TRENDS Evaluerer diagnostiske sensorer hos hjertesviktpasienter som mottar Boston Scientifics undersøkelses-ICM-system.

2. oktober 2026 oppdatert av: Boston Scientific Corporation

LUX-Dx hjertesviktsensorer i et innsettbart hjertemonitorsystem klinisk studie (LUX-Dx TRENDS)

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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

557

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Treatment Arm

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

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boston Scientific Corporation

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. mars 2021

Primær fullføring (Faktiske)

27. juli 2026

Studiet fullført (Faktiske)

27. juli 2026

Datoer for studieregistrering

Først innsendt

4. mars 2021

Først innsendt som oppfylte QC-kriteriene

5. mars 2021

Først lagt ut (Faktiske)

10. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C2118

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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