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Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

24. juli 2019 opdateret af: Edwards Lifesciences
The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a prospective, non-randomized, non-controlled observational clinical trial. Up to 200 subjects will be enrolled at up to 6 participating clinical sites. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic valve. Patients will be followed and assessed after implant for up to 5 years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

133

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Polen
      • Kraków, Polen, 31-202
        • Krakowski Szpital Specjalistyczny im. Jana Pawła II
      • Warsaw, Polen, 04-628
        • Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

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:

  • 18 years or older
  • Require replacement of aortic valve
  • Signed informed consent
  • Willing to return to study site for follow-up visits

Exclusion Criteria:

  • Active endocarditis/myocarditis (< 3 months)
  • Myocardial infarction (< 30 days)
  • Renal insufficiency/ End-stage renal disease
  • Life expectancy (< 1 year)
  • Requires multiple valve replacement/repair
  • Requiring emergent aortic valve surgery
  • Pregnant or lactating

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Aortic Bioprosthesis, Model 11000
Aortic valve replacement therapy
Procedure: Heart Valve Surgery
Implant of an aortic valve, Model 11000

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Antal tidlige uønskede hændelser divideret med antal forsøgspersoner (udtrykt som en procentdel)
Tidsramme: Hændelser, der opstår inden for 30 dage efter proceduren
Antal tidlige bivirkninger, der opstår inden for 30 dage efter proceduren divideret med antallet af tilmeldte forsøgspersoner gange 100
Hændelser, der opstår inden for 30 dage efter proceduren
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Tidsramme: Events occurring >= 31 days and up through 5 years post-implant
Number of late events divided by the total number of late patient years x 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Events occurring >= 31 days and up through 5 years post-implant

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subject's Average Mean Gradient Measurements
Tidsramme: Baseline through 5-Year (at each scheduled follow-up visit)
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.
Baseline through 5-Year (at each scheduled follow-up visit)
Subject's Average Effective Orifice Area Measurements
Tidsramme: Baseline through 5-Year (at each scheduled follow-up visit)
Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.
Baseline through 5-Year (at each scheduled follow-up visit)
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Tidsramme: 3-6 Months and 1 through 5 Years compared to baseline

The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.

Class I. Patients with cardiac disease but without resulting limitation of physical activity.

Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.

Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.

Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.

Symptoms of heart failure or the anginal syndrome may be present even at rest.
3-6 Months and 1 through 5 Years compared to baseline
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
Tidsramme: Baseline and one year follow-up

The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS).

The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status.

The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status.
Baseline and one year follow-up
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
Tidsramme: Baseline and 1 Year
The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
Baseline and 1 Year

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subject's Average White Blood Cell Count
Tidsramme: Baseline, 3-6 Months, and 1 through 5 Years
Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
Baseline, 3-6 Months, and 1 through 5 Years
Subject's Average Red Blood Cells Count
Tidsramme: Baseline, 3-6 Months, and 1 through 5 Years
Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.
Baseline, 3-6 Months, and 1 through 5 Years
Subject's Average Hemoglobin Count
Tidsramme: Baseline, 3-6 months, and 1 through 5 years
Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.
Baseline, 3-6 months, and 1 through 5 years
Subject's Average Hematocrit Percentage
Tidsramme: Baseline, 3-6 Months, and 1 through 5 Years
Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component(plasma) in the blood.
Baseline, 3-6 Months, and 1 through 5 Years
Subject's Average Platelet Count
Tidsramme: Baseline, 3-6 Months, and 1 through 5 Years
Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
Baseline, 3-6 Months, and 1 through 5 Years
Subject's Average Plasma Free Hemoglobin
Tidsramme: Baseline, 3-6 Months, and 1 through 5 Years
Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the liquid part of the blood (the serum).
Baseline, 3-6 Months, and 1 through 5 Years
Subject's Average Serum Creatinine
Tidsramme: Baseline
Laboratory Analysis of Serum Creatinine on blood drawn from subjects. Creatinine blood test is a test that measures kidney function.
Baseline
Subject's Average International Normalized Ratio
Tidsramme: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years

Laboratory Analysis of International Normalized Ratio (INR) on blood drawn from subjects.

The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot.
Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
Subject's Average Partial Thromboplastin Time
Tidsramme: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
Laboratory Analysis of partial thromboplastin time (PTT) on blood drawn from subjects. PTT is a blood test that looks at how long it takes for the blood to clot.
Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
Subject's Average Prothrombin Time
Tidsramme: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
Laboratory Analysis of Prothrombin Time (PT) on blood drawn from subjects. The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot.
Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years

Samarbejdspartnere og efterforskere

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

Sponsor

Edwards Lifesciences

Efterforskere

  • Ledende efterforsker: Jerzy Sadowski, MD, John Paul II Hospital
  • Ledende efterforsker: Jacek Rozanski, MD, The Cardinal Stefan Wyszynski Institute of Cardiology

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

Hjælpsomme links

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. juli 2011

Primær færdiggørelse (Faktiske)

1. juli 2018

Studieafslutning (Faktiske)

1. juli 2018

Datoer for studieregistrering

Først indsendt

18. juli 2012

Først indsendt, der opfyldte QC-kriterier

24. juli 2012

Først opslået (Skøn)

26. juli 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2010-03

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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Placeringer

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