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

8. januar 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2258

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

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

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

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: ST Monitoring Feature
ST segment continous monitoring feature enabled and programmed ON
Enhed: 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 navne:
  • ST Monitoring Feature

Hvad måler undersøgelsen?

Primære resultatmål

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

Samarbejdspartnere og efterforskere

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

Sponsor

Abbott Medical Devices

Efterforskere

  • Ledende efterforsker: Michael Gibson, MD, Boston Clinical Research Institute

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)

1. august 2011

Primær færdiggørelse (Faktiske)

1. juni 2017

Studieafslutning (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først indsendt

22. august 2011

Først indsendt, der opfyldte QC-kriterier

26. august 2011

Først opslået (Skøn)

29. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CRD_420

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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 .

Kliniske forsøg med Koronararteriesygdom

Kliniske forsøg med Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Benin

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner