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The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B (PARTNERII B)

27. august 2018 opdateret af: Edwards Lifesciences

The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients

The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Cohort B was a 1:1 randomized, controlled study independently powered to compare transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in patients who could not undergo surgery (inoperable).

Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT THV with the associated delivery system.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

560

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
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72211
        • Arkansas Heart Hospital/Clinic
    • California
      • La Jolla, California, Forenede Stater, 92037
        • Scripps Green Hospital
      • La Jolla, California, Forenede Stater, 92037
        • Scripps Memorial Hospital
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars-Sinai Medical Center
      • Sacramento, California, Forenede Stater, 95816
        • Mercy General Hospital
      • Stanford, California, Forenede Stater, 94305
        • Stanford University Medical Center
    • Colorado
      • Denver, Colorado, Forenede Stater, 80045
        • University of Colorado Hospital
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010
        • Washington Hospital Center (WHC)
    • Florida
      • Clearwater, Florida, Forenede Stater, 33756
        • Morton Plant Hospital
      • Gainesville, Florida, Forenede Stater, 32610
        • University of Florida, Gainesville
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • Emory University Hospital
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern Hospital
      • Springfield, Illinois, Forenede Stater, 62701
        • Prairie Education And Research Cooperative
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University Health-Methodist Hospital
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • The University of Iowa
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • University of Louisville - Jewish Hospital
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Minneapolis Heart Institute Foundation
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • Saint Luke's Hospital of Kansas City Mid America
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University - Barnes Jewish Hospital
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68526
        • Nebraska Heart Institute
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Newark, New Jersey, Forenede Stater, 07112
        • Newark Beth Israel
    • New York
      • Manhasset, New York, Forenede Stater, 11030
        • North Shore University Hospital, NY
      • Mineola, New York, Forenede Stater, 11501
        • Winthrop University Hospital
      • New York, New York, Forenede Stater, 10032
        • Columbia University Medical Center
      • New York, New York, Forenede Stater, 10021
        • Cornell University
    • North Carolina
      • Charleston, North Carolina, Forenede Stater, 29425
        • Medical University of South Carolina Charleston
      • Greenville, North Carolina, Forenede Stater, 27834
        • East Carolina Heart Institute at East Carolina University
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • The Christ Hospital, Cincinnati
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73135
        • Oklahoma Heart Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania Hospital
      • York, Pennsylvania, Forenede Stater, 17403
        • York Hospital
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38120
        • Baptist Memorial Hospital
    • Texas
      • Austin, Texas, Forenede Stater, 78756
        • Austin Heart, PLLC
      • Dallas, Texas, Forenede Stater, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, Forenede Stater, 75093
        • The Heart Hospital Baylor Plano
      • Houston, Texas, Forenede Stater, 77030
        • The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
      • San Antonio, Texas, Forenede Stater, 78229-3900
        • University of Texas Health Science Center at San Antonio (UTHSCSA)
    • Utah
      • Murray, Utah, Forenede Stater, 84157
        • Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22904
        • University of Virginia
      • Norfolk, Virginia, Forenede Stater, 23507
        • Sentara Norfolk General Hospital
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin - Madison

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

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

  1. Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
  2. The probability of death or serious, irreversible morbidity is greater than or equal to 50%.
  3. The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
  4. The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
  5. The study patient agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone follow-up.

Exclusion Criteria

  1. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
  2. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta. (Transfemoral)
  3. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
  4. It is known that the patient is currently enrolled in the PARTNER I Trial or was withdrawn from the PARTNER I Trial prior to endpoint analysis.
  5. Active bacterial endocarditis within 6 months (180 days) of procedure.

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: TAVR - SAPIEN XT
TAVR (transaortic valve replacement) with SAPIEN XT
Enhed: TAVR Implantation with SAPIEN XT
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
Aktiv komparator: TAVR - SAPIEN
TAVR (transaortic valve replacement) with SAPIEN is the control arm
Enhed: TAVR Implantation with SAPIEN
Inoperable operable patients requiring the transcatheter aortic heart valve replacement

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization
Tidsramme: 1 Year
All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year
1 Year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
NYHA Classification - Change From Baseline
Tidsramme: Baseline and 1 Year
New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.
Baseline and 1 Year
Total Aortic Regurgitation - Change From Baseline
Tidsramme: 1 Year

Total aortic regurgitation was assessed by the core lab as 'Grade 0' = None, 'Grade 1+' = Trace, 'Grade 2+' = Mild, 'Grade 3+' = Moderate, and 'Grade 4+' = Severe.

Total regurgitation at one year was analyzed in the valve implant population.
1 Year
Effective Orifice Area - Change From Baseline
Tidsramme: 1 Year
1 Year

Samarbejdspartnere og efterforskere

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

Sponsor

Edwards Lifesciences

Samarbejdspartnere

American College of Cardiology

Efterforskere

  • Ledende efterforsker: Martin B Leon, MD, Columbia University

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 (Faktiske)

9. marts 2011

Primær færdiggørelse (Faktiske)

1. maj 2013

Studieafslutning (Faktiske)

30. maj 2017

Datoer for studieregistrering

Først indsendt

17. januar 2014

Først indsendt, der opfyldte QC-kriterier

8. juli 2014

Først opslået (Skøn)

9. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2010-12-PIIB

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 Calcific aortastenose

Kliniske forsøg med TAVR Implantation with SAPIEN XT

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Egypt

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner