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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 opdateret af: CardioKinetix, Inc

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

Treatment of ischemic heart failure.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

331

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

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

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 til 79 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Parachute Implant and All Appropriate Medical Therapy (AAMT)
Enhed: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
CardioKinetix Parachute implant and all appropriate medical therapy
Ingen indgriben: All Appropriate Medical Therapy (AAMT)

Hvad måler undersøgelsen?

Primære resultatmål

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

Samarbejdspartnere og efterforskere

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

Sponsor

CardioKinetix, Inc

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. december 2012

Primær færdiggørelse (Faktiske)

1. juni 2017

Studieafslutning (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først indsendt

4. juni 2012

Først indsendt, der opfyldte QC-kriterier

6. juni 2012

Først opslået (Skøn)

8. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VA0956

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 .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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