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Self-Centering Guide Catheter Feasibility Study

27. august 2018 opdateret af: Boston Scientific Corporation
An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A prospective, open-label, single-arm feasibility study evaluating the Self-Centering Guide Catheter. All subjects who are candidates for transcatheter aortic valve replacement (TAVR) of a native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques will be evaluated for enrollment in this study. The Self-Centering Guide Catheter is intended to facilitate delivery of a guidewire across a stenotic native aortic valve and into the left ventricle.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

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
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic

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 110 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subject must be at least 18 years of age.
  • Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
  • Subject is eligible for and is an acceptable candidate for transcatheter aortic valve replacement of a stenotic (aortic valve area ≤1 cm2, aortic jet velocity ≥4.0 m/s, or mean gradient ≥40 mmHg) native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques.

Exclusion Criteria:

  • Subject has known hypersensitivity to the components of the device (e.g., polyether block amide, fluoropolymers, nickel, platinum, tantalum, titanium).
  • Subject has a pre-existing prosthetic aortic valve.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Enhedens gennemførlighed
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Self-Centering Guide Catheter
Subjects who provided written informed consent and an attempt is made to insert the Self-Centering Guide Catheter into the subject's femoral artery.
Enhed: Self-Centering Guide Catheter

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Self-Centering Guide Catheters Successfully Used to Deliver a Guide Wire Through the Self-Centering Guide Catheter Across the Stenotic Native Aortic Valve Into the Left Ventricle
Tidsramme: Through study completion, up to 72 hours post-procedure
This outcome will be assessed via physician determination and will be recorded in the case report form.
Through study completion, up to 72 hours post-procedure

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time From Insertion of the Self-Centering Guide Catheter Into the Body to Successful Placement of a PTFE-coated Guidewire Across the Stenotic Native Aortic Valve
Tidsramme: Through study completion, up to 72 hours post-procedure
Through study completion, up to 72 hours post-procedure
Time From Insertion of the Self-Centering Guide Catheter Into the Body to Removal of the Self-Centering Guide Catheter From the Body
Tidsramme: Through study completion, up to 72 hours post-procedure
Through study completion, up to 72 hours post-procedure
Number of Attempts Made to Cross the Stenotic Native Aortic Valve With a PTFE-coated Guidewire
Tidsramme: Through study completion, up to 72 hours post-procedure
Through study completion, up to 72 hours post-procedure
Successful Recapture of the Distal Self-centering Basket of the Device Into the Guide and Withdrawal of the Self-Centering Guide Catheter Through the Guide System
Tidsramme: Through study completion, up to 72 hours post-procedure
The outcome measure of successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system will be assessed via physician assessment of the self-centering basket recapture and will be recorded in the case report form.
Through study completion, up to 72 hours post-procedure
Number of Self-Centering Guide Catheters With Device Success
Tidsramme: Through study completion, up to 72 hours post-procedure
Device success is defined as successful delivery of a guide wire through the Self-Centering Guide Catheter across the stenotic native aortic valve into the left ventricle and successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system. This outcome will be assessed via physician determination and will be recorded in the case report form.
Through study completion, up to 72 hours post-procedure
Number of Participants With Stroke
Tidsramme: 72 hours post-procedure
72 hours post-procedure
Number of Participants With Cardiac Tamponade
Tidsramme: 72 hours post-procedure
72 hours post-procedure
Death, All-cause, Cardiovascular, and Non-cardiovascular
Tidsramme: 72 hours post-procedure
72 hours post-procedure
Any Device-related Adverse Event
Tidsramme: 72 hours post-procedure
72 hours post-procedure
Any Adverse Event Occurring While the Self-Centering Guide Catheter is in the Subject
Tidsramme: 72 hours post-procedure
72 hours post-procedure
Number of Device Deficiencies Including But Not Limited to Failures, Malfunctions, Use Errors, Product Nonconformities, and Labeling Errors
Tidsramme: 72 hours post-procedure
All device deficiencies including but not limited to failures, malfunctions, use errors, product nonconformities, and labeling errors will be recorded in the case report form
72 hours post-procedure

Samarbejdspartnere og efterforskere

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

Sponsor

Boston Scientific Corporation

Efterforskere

  • Ledende efterforsker: Rajiv Gulati, MD, PhD, Mayo Clinic

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)

12. maj 2016

Primær færdiggørelse (Faktiske)

6. oktober 2016

Studieafslutning (Faktiske)

6. oktober 2016

Datoer for studieregistrering

Først indsendt

17. december 2015

Først indsendt, der opfyldte QC-kriterier

21. december 2015

Først opslået (Skøn)

24. december 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • S2360

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 .

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