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A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System (PARACHUTE IV)

21. juni 2017 oppdatert av: CardioKinetix, Inc

Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease

Treatment of ischemic heart failure.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

331

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6E 1M7
        • St. Paul's Hospital
  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater, 85013
        • Arizona Heart
      • Tucson, Arizona, Forente stater, 85724
        • University of Arizona Medical Center
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72211
        • Arkansas Heart
    • California
      • Los Angeles, California, Forente stater, 90033
        • University of Southern California (USC)
      • Los Angeles, California, Forente stater, 90069
        • Cedars-Sinai Medical Center
      • Sacramento, California, Forente stater, 95817
        • UC Davis Medical Center
    • Florida
      • Clearwater, Florida, Forente stater, 33756
        • Morton Plant Hospital - Heart and Vascular Institute of Florida
      • Delray Beach, Florida, Forente stater, 33444
        • Delray Medical Center
      • Tallahassee, Florida, Forente stater, 32308
        • Tallahassee Research Institute
      • Tampa, Florida, Forente stater, 33613
        • Florida Hospital Tampa - Pepin Heart Institute
    • Georgia
      • Atlanta, Georgia, Forente stater, 30309
        • Piedmont Atlanta Hospital
    • Idaho
      • Coeur d'Alene, Idaho, Forente stater, 83814
        • Kootenai Heart Clinics
    • Illinois
      • Evanston, Illinois, Forente stater, 60201
        • Evanston Hospital
      • Naperville, Illinois, Forente stater, 60566
        • Advocate Medical Group - Midwest Heart Foundation
      • Springfield, Illinois, Forente stater, 62701
        • Prairie Education and Research Cooperative - St. John's Hospital
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46260
        • St. Vincent Heart Center of Indiana
    • Iowa
      • Des Moines, Iowa, Forente stater, 50266
        • Iowa Heart Center
      • Iowa City, Iowa, Forente stater, 52242-1081
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • University of Kansas Hospital
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40503
        • Baptist Health Lexington
      • Lexington, Kentucky, Forente stater, 40504
        • St Joseph Hospital/Kentucky One
      • Louisville, Kentucky, Forente stater, 40202
        • Jewish Hospital/Louisville
    • Louisiana
      • Houma, Louisiana, Forente stater, 70360
        • Cardiovascular Institute of the South
      • New Orleans, Louisiana, Forente stater, 70121
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, Forente stater, 70112
        • LSU Health Sciences Center
    • Maryland
      • Baltimore, Maryland, Forente stater, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48197
        • St. Joseph Mercy-Michigan Heart
      • Midland, Michigan, Forente stater, 48670
        • MidMichigan Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • University of Minnesota Medical Center
      • Saint Paul, Minnesota, Forente stater, 55102
        • United Heart and Vascular Clinic
    • Missouri
      • Kansas City, Missouri, Forente stater, 64111
        • St. Luke's MAHI
    • Nebraska
      • Lincoln, Nebraska, Forente stater, 68526
        • Nebraska Heart Hospital
    • New Jersey
      • Browns Mills, New Jersey, Forente stater, 08015
        • Deborah Heart and Lung Center
      • Hackensack, New Jersey, Forente stater, 07601
        • Hackensack UMC
    • New York
      • Buffalo, New York, Forente stater, 14203
        • Gates Vascular Institute/Buffalo General Hospital
      • New York, New York, Forente stater, 10029
        • Mount Sinai Medical Center
      • New York, New York, Forente stater, 10065
        • New York Presbyterian Hospital - Cornell Campus
      • Rochester, New York, Forente stater, 14643
        • Univ. Of Rochester Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, Forente stater, 27157
        • Wake Forest Baptist Health
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45219
        • The Christ Hospital Lindner Research Center
      • Cleveland, Ohio, Forente stater, 44106
        • University Hospitals
      • Columbus, Ohio, Forente stater, 43210
        • The Ohio State University
      • Columbus, Ohio, Forente stater, 43214
        • Ohio Health Research Institute/Riverside Methodist Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73120
        • Oklahoma Heart Hospital
      • Oklahoma City, Oklahoma, Forente stater, 73112
        • Integris Baptist Medical Center
    • Pennsylvania
      • Lancaster, Pennsylvania, Forente stater, 17062
        • Lancaster General Hospital
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19141
        • Einstein Healthcare Network Cardiology
      • Pittsburgh, Pennsylvania, Forente stater, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • University of Pittsburgh Medical Center - Presbyterian Hospital
      • Wormleysburg, Pennsylvania, Forente stater, 17043
        • Pinnacle Health Cardiovascular Institute
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02906
        • The Miriam Hospital
    • Tennessee
      • Kingsport, Tennessee, Forente stater, 37660
        • Wellmont Holston Valley Medical Center
      • Knoxville, Tennessee, Forente stater, 37934
        • Tennova Healthcare - Turkey Creek Medical Center
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt University
      • Nashville, Tennessee, Forente stater, 37205
        • Saint Thomas West Hospital
    • Texas
      • Austin, Texas, Forente stater, 78745
        • Texas Cardiac Arrhythmia Research Foundation
      • Houston, Texas, Forente stater, 77030
        • Memorial Hermann Hospital
      • Houston, Texas, Forente stater, 77030
        • Texas Heart Institute at St. Luke's Episcopal Hospital
      • Houston, Texas, Forente stater, 77056
        • The Methodist Hospital
    • Utah
      • Salt Lake City, Utah, Forente stater, 84132
        • University of Utah
    • Virginia
      • Falls Church, Virginia, Forente stater, 22042
        • Inova Heart and Vascular, Fairfax
      • Norfolk, Virginia, Forente stater, 23507
        • Sentara Cardiovascular Research Institute
      • Richmond, Virginia, Forente stater, 23298
        • Virginia Commonwealth University Medical Center
    • Washington
      • Seattle, Washington, Forente stater, 98122
        • Swedish Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53215
        • Aurora St. Luke's Medical Center

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 til 79 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Candidates for this study must meet ALL of the following inclusion criteria:

Clinical Inclusion Criteria:

  • Age ≥ 18 and ≤ 79 years.
  • Body Mass Index (BMI) ≤ 40.
  • Symptomatic ischemic heart failure (New York Heart Association (NYHA) Class III or "ambulatory" Class IV as determined through the use of the SAS) post Myocardial Infarction (MI) in the Left Anterior Descending (LAD) territory at least 60 days prior to enrollment.
  • Patient is not hospitalized at the time of enrollment.
  • Receiving appropriate medical treatment for heart failure according to the current American College of Cardiology (ACC)/American Heart Association (AHA) Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment.
  • The patient or the patient's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
  • The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.

Inclusion Criteria based on Imaging:

  • 15% ≤ Left Ventricular Ejection Fraction (LVEF) ≤ 35% by Transthoracic Echocardiogram (TTE).
  • Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by TTE.
  • Left ventricle must have appropriate anatomy (size and morphology) for implant placement using Cardiac Computed Tomography (CT) and confirmed by LV gram

Candidates will be excluded from the study if ANY of the following conditions apply:

Clinical Exclusion Criteria:

  • Untreated clinically significant coronary artery disease requiring revascularization.
  • Cardiogenic shock within 72 hours of enrollment.
  • Patient has received a pacemaker, Implantable Cardioverter Defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) within 60 days of enrollment.
  • Excessive wall motion abnormalities outside the anteroapical region.
  • Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  • End stage renal disease requiring chronic dialysis.
  • Obstructive Sleep Apnea (OSA): unless compliant on CPAP therapy or successful surgery.
  • Hemoglobin < 10 g/dl (female), < 12 g/dl (male) or Creatinine > 2.5mg/dl.
  • Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  • Active peptic ulcer or GI bleeding within the past 3 months.
  • A known hypersensitivity or contraindication to aspirin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre-medicated.
  • Ongoing sepsis, including active endocarditis.
  • Life expectancy < 1 year due to associated non-cardiac co-morbid conditions or currently on the heart transplant lists.
  • Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the patient from appropriate consent.
  • Currently participating in an investigational drug or another device study (prior to primary endpoint reached).
  • Female patients with childbearing potential and a positive urine pregnancy test .

Anatomical Exclusion Criteria:

  • Pre-existing prosthetic heart valve in mitral or aortic position.
  • Valvular stenosis or regurgitation (tricuspid, aortic or mitral) > 2+.
  • Presence of anatomic anomalies (including severe calcification) detected by cardiac imaging (echocardiogram, Computed Tomography (CT), or LV gram) preventing unimpeded deployment and/or operation of the Parachute Implant

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Parachute Implant and All Appropriate Medical Therapy (AAMT)
Enhet: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
CardioKinetix Parachute implant and all appropriate medical therapy
Ingen inngripen: All Appropriate Medical Therapy (AAMT)

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Death or re-hospitalization for Worsening Heart Failure (WHF)
Tidsramme: At least 1 year
At least 1 year

Samarbeidspartnere og etterforskere

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

Sponsor

CardioKinetix, Inc

Etterforskere

  • Hovedetterforsker: Marco A Costa, MD, PhD, University Hospitals
  • Hovedetterforsker: Leslie Saxon, MD, University of Southern California

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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

1. desember 2012

Primær fullføring (Faktiske)

1. juni 2017

Studiet fullført (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først innsendt

4. juni 2012

Først innsendt som oppfylte QC-kriteriene

6. juni 2012

Først lagt ut (Anslag)

8. juni 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. juni 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juni 2017

Sist bekreftet

1. juni 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • VA0956

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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