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Pilot Trial: Comparison of Flow Patterns

26. marts 2018 opdateret af: Alfred A Kocher, MD, Medical University of Vienna

Pilot Trial: Comparison of Flow Patterns. Is There a Difference Between sewed-in and "Sutureless" Bioprosthetic Aortic Heart Valves?

The purpose of this study is to determine why sutureless aortic bioprostheses apparently offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients who underwent aortic valve replacement.

Our approach to address this question is the combination of clinical data with the application of specifically validated experimental and computer based analyses to compare the performance of these valves under patient-specific conditions.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Østrig
      • Vienna, Østrig, 1090
        • Rekruttering
        • Medical University of Vienna
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Alfred Kocher, MD
        • Underforsker:
          • Claus Rath, MD
        • Underforsker:
          • Martin Andreas, MD
        • Underforsker:
          • Dominik Wiedemann, MD
        • Underforsker:
          • Guenther Laufer, MD
        • Underforsker:
          • Christian Loewe, MD
        • Underforsker:
          • Raphael Rosenhek, MD

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:

  • Patient underwent open aortic valve replacement with either an Edwards Magna Ease or an Edwards Intuity valve
  • Implanted valve size 23mm
  • Surgical access via full sternotomy or hemisternotomy
  • Intuity Valve System implanted by one of the clinical investigators of the TRITON trial (http://clinicaltrials.gov/show/NCT01445171) at the Medical University of Vienna
  • Post-operative ejection fraction ≥50%
  • Sinus-Rhythm
  • Ability to understand and comply with study procedures
  • Signed informed consent

Exclusion Criteria:

  • Under 18 years of age
  • Emergency surgery
  • Pregnancy
  • Previous aortic root replacement
  • Previous aortic valve replacement
  • Previous or concomitant root enlargement
  • Previous or concomitant repair of the ascending aorta
  • Paravalvular leakage
  • Ectasia of the ascending aorta
  • Previous or concomitant myomectomy
  • Concomitant replacement or repair of valves other than aortic
  • Usage of more than 3 sutures for implantation of the Intuity Valve System
  • Heavily calcified aortic root
  • Glomerular filtration rate (GFR) < 30 ml/min
  • Inability to understand or comply with study procedures
  • Known allergic reaction to iodinated, non-ionic contrast agents

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: "Sutureless" valve

Patients who underwent aortic valve replacement with a "sutureless" aortic valve.

An echocardiogram and a cardiac CT-scan will be conducted.
Stråling: Cardiac CT-scan

ECG gated CT angiography of the heart will be performed on a 128-slice dual-source and two Stellar detectors CT system with retrospective ECG-gating (Siemens/SOMATOM Definition Flash - Siemens, Germany, 100kV, 395.75 mAs).

In details, multi-phase images will be acquired to reconstruct between 10 and 100% of the cardiac cycle (10% increments) with a slice thickness of 1 mm. Examination will include left ventricular outflow tract, aortic root, coronary sinus, ascending aorta together with the prosthetic valves.
Andet: "Sewed-in" valve
Patients who underwent aortic valve replacement with a "sewed-in" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted.
Stråling: Cardiac CT-scan

ECG gated CT angiography of the heart will be performed on a 128-slice dual-source and two Stellar detectors CT system with retrospective ECG-gating (Siemens/SOMATOM Definition Flash - Siemens, Germany, 100kV, 395.75 mAs).

In details, multi-phase images will be acquired to reconstruct between 10 and 100% of the cardiac cycle (10% increments) with a slice thickness of 1 mm. Examination will include left ventricular outflow tract, aortic root, coronary sinus, ascending aorta together with the prosthetic valves.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Comparison of maximum and minimum velocity under patient specific conditions
Tidsramme: between 6 months and 4 years after aortic valve replacement
between 6 months and 4 years after aortic valve replacement
Comparison of the effective orifice area under patient specific conditions
Tidsramme: between 6 months and 4 years after aortic valve replacement
between 6 months and 4 years after aortic valve replacement
Comparison of the percentage of turbulent flow under patient specific conditions
Tidsramme: between 6 months and 4 years after aortic valve replacement
between 6 months and 4 years after aortic valve replacement
Comparison of the pressure drop under patient specific conditions
Tidsramme: between 6 months and 4 years after aortic valve replacement
between 6 months and 4 years after aortic valve replacement

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients.
Tidsramme: between 6 months and 4 years after aortic valve replacement

The first secondary outcome measure is the comparison of

-pressure gradients

as computed by the model against the same data collected standardly with echocardiographic technique. Differences will be quantified.

If positive (< 10%), this assessment would enhance the use of patient-specific models in clinics as a predictive tool for detailed haemodynamics."
between 6 months and 4 years after aortic valve replacement
Patient-specific, computer simulated peak velocity compared to echocardiographically obtained peak velocity.
Tidsramme: between 6 months and 4 years after aortic valve replacement

The second secondary outcome measure is the comparison of

-peak velocity

as computed by the model against the same data collected standardly with echocardiographic technique. Differences will be quantified.

If positive (< 10%), this assessment would enhance the use of patient-specific models in clinics as a predictive tool for detailed haemodynamics."
between 6 months and 4 years after aortic valve replacement

Samarbejdspartnere og efterforskere

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

Sponsor

Medical University of Vienna

Samarbejdspartnere

University College, London

Efterforskere

  • Ledende efterforsker: Alfred Kocher, MD, Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna

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. oktober 2014

Primær færdiggørelse (Forventet)

1. december 2020

Studieafslutning (Forventet)

1. december 2021

Datoer for studieregistrering

Først indsendt

22. oktober 2014

Først indsendt, der opfyldte QC-kriterier

7. november 2014

Først opslået (Skøn)

11. november 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. marts 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. marts 2018

Sidst verificeret

1. marts 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1790/2013-1

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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