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ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients (AnalyzeST)

8. januar 2021 oppdatert av: Abbott Medical Devices

ST Monitoring to Detect ACS Events in ICD Patients

This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in St Jude Medical ICD systems.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a prospective, non-randomized, multicenter, pivotal IDE study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in the Fortify® ST, Fortify Assura® ST, and Ellipse® ST family of devices, as well as any future St Jude Medical devices with the same ST Monitoring Feature capabilities. Effectiveness of the device will be evaluated by analyzing the sensitivity of the ST Monitoring Feature to detect clinical events. In addition, safety of the ST Monitoring Feature will be evaluated by demonstrating a low percentage of patients with false positive events.

Studietype

Intervensjonell

Registrering (Faktiske)

2258

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, 35233
        • University Hospital - Univ. of Alabama at Birmingham (UAB)
      • Birmingham, Alabama, Forente stater, 35209
        • Cardiovascular Associates PC
      • Birmingham, Alabama, Forente stater, 35213
        • Cardiovascular Associates PC
      • Huntsville, Alabama, Forente stater, 35801
        • Heart Center Research, LLC
    • Arizona
      • Mesa, Arizona, Forente stater, 85206
        • Banner Heart Hospital
      • Phoenix, Arizona, Forente stater, 85006
        • Arizona Arrhythmia Research Center
      • Tucson, Arizona, Forente stater, 85710
        • Carondelet Specialist Group - Southwest Heartr
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72211
        • Arkansas Heart Hospital
      • Little Rock, Arkansas, Forente stater, 72205
        • Arkansas Cardiology
    • California
      • Bakersfield, California, Forente stater, 93308
        • Central Cardiology
      • Concord, California, Forente stater, 94520
        • John Muir Medical Center
      • Fullerton, California, Forente stater, 92835
        • St. Jude Hospital
      • Glendale, California, Forente stater, 91204
        • Glendale Memorial Hospital and Medical Center
      • Glendale, California, Forente stater, 91203
        • Cardia Care Specialists
      • La Jolla, California, Forente stater, 92037
        • Scripps Memorial Hospital La Jolla
      • Long Beach, California, Forente stater, 90806
        • Long Beach Memorial
      • Los Angeles, California, Forente stater, 90027
        • Kaiser Permanente Los Angeles
      • Los Angeles, California, Forente stater, 90033
        • USC University Hospital
      • Northridge, California, Forente stater, 91325
        • Cardiac Rhythm Specialists, Inc.
      • Sacramento, California, Forente stater, 95819
        • Sutter Memorial Hospital
    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80907
        • Colorado Cardiac Alliance
    • Connecticut
      • Norwalk, Connecticut, Forente stater, 06851
        • Cardiology Associates of Fairfield County
    • Delaware
      • Newark, Delaware, Forente stater, 19718
        • Christiana Hospital
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20010
        • Washington Hospital Center
    • Florida
      • Bradenton, Florida, Forente stater, 34208
        • Manatee Memorial Hospital
      • Daytona Beach, Florida, Forente stater, 32114
        • Cardiology Consultants PA
      • Fort Lauderdale, Florida, Forente stater, 33308
        • Holy Cross Hospital
      • Jacksonville, Florida, Forente stater, 32216
        • First Coast Cardiovascular Institute
      • Lakeland, Florida, Forente stater, 33805
        • Watson Clinic Center
      • Miami, Florida, Forente stater, 33136
        • University of Miami Hospital
      • Ocala, Florida, Forente stater, 34471
        • Munroe Regional Medical Center
      • Orlando, Florida, Forente stater, 32803
        • Florida Hospital Orlando
    • Georgia
      • Athens, Georgia, Forente stater, 30606
        • Athens Regional Medical Center
      • Gainesville, Georgia, Forente stater, 30501
        • Northeast Georgia Heart Center, Pc
      • Rome, Georgia, Forente stater, 30165
        • Redmond Regional Medical Center
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96813
        • The Queen's Medical Center
    • Illinois
      • Chicago, Illinois, Forente stater, 60565
        • Northwestern Memorial Hospital
    • Indiana
      • Fort Wayne, Indiana, Forente stater, 46804
        • Northern Indiana Research Alliance
    • Iowa
      • West Des Moines, Iowa, Forente stater, 50266
        • Iowa Heart Center
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • Mid-America Cardiology Associates, PC
    • Kentucky
      • Ashland, Kentucky, Forente stater, 41101
        • Kentucky Heart Institute / King's Daughter
      • Lexington, Kentucky, Forente stater, 40503
        • Central Baptist Hospital
      • Louisville, Kentucky, Forente stater, 40202
        • University of Louisville
    • Louisiana
      • Hammond, Louisiana, Forente stater, 70403
        • Heart Clinic of Hammond
      • New Orleans, Louisiana, Forente stater, 70121
        • Ochsner Medical Center
    • Maryland
      • Baltimore, Maryland, Forente stater, 21237
        • Medstar Research Institute
      • Rockville, Maryland, Forente stater, 20850
        • Shady Grove Adventist Hospital
    • Massachusetts
      • Worcester, Massachusetts, Forente stater, 01655
        • University of Massachusettts Medical Center
    • Michigan
      • Lansing, Michigan, Forente stater, 48910
        • Thoracic Cardiovascular Healthcare Foundation
      • Southfield, Michigan, Forente stater, 48075
        • Providence Hospital
      • Traverse City, Michigan, Forente stater, 49684
        • Munson Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55417
        • VA Medical Center Minneapolis
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic
    • Mississippi
      • Jackson, Mississippi, Forente stater, 39216
        • Jackson Heart Clinic
    • Missouri
      • North Kansas City, Missouri, Forente stater, 64116
        • North Kansas City Hospital
      • Saint Louis, Missouri, Forente stater, 63141
        • Mercy Hospital St. Louis
      • Springfield, Missouri, Forente stater, 65804
        • Mercy Medical Research Institute
    • New Jersey
      • Browns Mills, New Jersey, Forente stater, 08015
        • Deborah Heart and Lung Center
      • Cherry Hill, New Jersey, Forente stater, 08034
        • Lourdes Cardiology Services
      • Englewood, New Jersey, Forente stater, 07631
        • Englewood Hospital & Medical Center
      • Haddon Heights, New Jersey, Forente stater, 08035
        • Cardiovascular Associates of the Delaware Valley
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87102
        • New Mexico Heart Institute
      • Las Cruces, New Mexico, Forente stater, 88011
        • Southwest Heart PC
    • New York
      • Buffalo, New York, Forente stater, 14215
        • Buffalo Heart group
      • Stony Brook, New York, Forente stater, 11794
        • Stony Brook Medical Center
    • North Carolina
      • Greensboro, North Carolina, Forente stater, 27401
        • LeBauer Cardiovascular Research Foundation
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Forsyth Medical Center
    • Ohio
      • Akron, Ohio, Forente stater, 44304
        • Northeast Ohio Cardiovascular Associates
      • Cleveland, Ohio, Forente stater, 44195
        • The Cleveland Clinic Foundation
      • Cleveland, Ohio, Forente stater, 44106
        • University Hospitals Of Cleveland
      • Columbus, Ohio, Forente stater, 43214
        • Ohio Health Research Institute
      • Columbus, Ohio, Forente stater, 43210
        • Ohio State Univeristy
      • Elyria, Ohio, Forente stater, 44035
        • EMH Regional Medical Center
      • Toledo, Ohio, Forente stater, 43614
        • University of Toledo Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74104
        • Oklahoma Heart Institute at Utica
    • Pennsylvania
      • Camp Hill, Pennsylvania, Forente stater, 17011
        • Capital Cardiovascular Associates
      • Hershey, Pennsylvania, Forente stater, 17033
        • Penn State Milton Hershey Medical Center
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • University of Pittsburgh Medical Center
      • Pittsburgh, Pennsylvania, Forente stater, 15212
        • Allegheny-Singer Research Institute
      • Sayre, Pennsylvania, Forente stater, 18840
        • Donald Guthrie Foundation for Education and Research
    • South Carolina
      • Columbia, South Carolina, Forente stater, 29204
        • Columbia Cardiology Consultants
      • Greenville, South Carolina, Forente stater, 29607
        • Upstate Cardiology
      • Spartanburg, South Carolina, Forente stater, 29303
        • Spartanburg Regional Medical Center
    • Tennessee
      • Johnson City, Tennessee, Forente stater, 37601
        • Cardiology Consultants
      • Memphis, Tennessee, Forente stater, 38104
        • Methodist University Hospital
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt Medical Center
      • Nashville, Tennessee, Forente stater, 37205
        • St. Thomas Hospital Heart
    • Texas
      • Amarillo, Texas, Forente stater, 73106
        • Cardiology Center of Amarillo, LLP
      • Dallas, Texas, Forente stater, 75216
        • VA Medical Center Dallas
      • San Antonio, Texas, Forente stater, 78201
        • South Texas Cardiovascular Consultants
      • Temple, Texas, Forente stater, 76508
        • Scott & White Memorial Hospital
      • Tyler, Texas, Forente stater, 75701
        • Cardiovascular Associates of East Texas
    • Utah
      • Ogden, Utah, Forente stater, 84403
        • McKay-Dee Heart Services
    • Virginia
      • Norfolk, Virginia, Forente stater, 23507
        • Sentara Norfolk General Hospital
      • Richmond, Virginia, Forente stater, 23249
        • Hunter Holmes McGuire VAMC
    • Washington
      • Bellevue, Washington, Forente stater, 98004
        • The Hope Heart Institute
      • Seattle, Washington, Forente stater, 98101
        • The Heart Institute at Virginia Mason

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

Inclusion Criteria:

  • Eligible patients will meet all of the following:

    1. Have an indication for an ICD implantation or pulse generator change
    2. Have documented coronary artery disease. Documented coronary artery disease is defined as having at least one of the following present a) evidence of a prior MI on ECG and/or cardiac enzymes, b) prior revascularization (by coronary artery bypass grafting or percutaneous coronary intervention) c) angina and/or ST-T wave abnormalities indicative of ischemia on exercise stress test, nuclear stress test, or echo stress test, or d) coronary artery disease diagnosed by coronary angiography.
    3. Willing and able to comply with protocol requirements, including keeping all required visits
    4. Willing to participate in the study and able to sign an IRB approved informed consent form
    5. Be at least 18 years of age when enrolled in the study

Exclusion Criteria:

  • Patients will be excluded if they meet any of the following:

    1. Are pacemaker dependent (defined as a need for ventricular pacing ≥ 20% of the time)
    2. Have NYHA Class IV Heart Failure
    3. Have persistent or permanent atrial fibrillation
    4. Have a known history of intermittent Bundle Branch Block
    5. Pregnant or planning a pregnancy during the study participation
    6. Have a life expectancy of < 1 year due to any condition
    7. Are currently participating in a clinical investigation that includes an active treatment arm.

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: ST Monitoring Feature
ST segment continous monitoring feature enabled and programmed ON
Enhet: Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
Andre navn:
  • ST Monitoring Feature

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Number of Patients Who Experience a False Positive ST Detection in 12 Months FU
Tidsramme: 12 months
12 months

Samarbeidspartnere og etterforskere

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

Sponsor

Abbott Medical Devices

Etterforskere

  • Hovedetterforsker: Michael Gibson, MD, Boston Clinical Research Institute

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)

1. august 2011

Primær fullføring (Faktiske)

1. juni 2017

Studiet fullført (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først innsendt

22. august 2011

Først innsendt som oppfylte QC-kriteriene

26. august 2011

Først lagt ut (Anslag)

29. august 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. januar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. januar 2021

Sist bekreftet

1. januar 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CRD_420

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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. .

Kliniske studier på Koronararteriesykdom

Kliniske studier på Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Kosovo

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

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