Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

AMPLATZER Cardiac Plug Clinical Trial

2. april 2020 opdateret af: Abbott Medical Devices

Amplatzer Cardiac Plug Clinical Trial

The objective of this study is to evaluate the safety and effectiveness of the ACP in subjects with nonvalvular atrial fibrillation by demonstrating that the device is non-inferior to optimal medical therapy (OMT) with respect to the primary effectiveness endpoint and superior to OMT with respect to primary safety endpoint.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

97

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
    • California
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, Forenede Stater, 90017
        • Good Samaritan Hospital
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado Denver
      • Littleton, Colorado, Forenede Stater, 80120
        • South Denver Cardiology Associates
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • Emory Midtown Hospital and Emory University Hospital
      • Atlanta, Georgia, Forenede Stater
        • St. Joseph's Hospital and Research Institute
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa Hospitals & Clinics
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40506
        • University of Kentucky
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Spectrum Health
      • Southfield, Michigan, Forenede Stater, 48075
        • Providence Hospital
    • Minnesota
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • St. Cloud Hospital/CentraCare Heart and Vascular Clinic
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • HealthEast St. Joseph's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania
      • York, Pennsylvania, Forenede Stater, 17405
        • York Hospital
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29401
        • Roper Hospital/PMG Research of Charleston
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Memorial Hermann Hospital
    • Wisconsin
      • Wausau, Wisconsin, Forenede Stater, 54401
        • Aspirus Heart & Vascular Institute

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:

  • Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation
  • Subject must be ≥18 years of age
  • Subject must be on warfarin or dabigatran therapy
  • Subject must be eligible for long term warfarin or dabigatran therapy
  • Subject must have a CHADS(2) score of 2 or greater

Summary of Exclusion Criteria:

  • Subject who requires warfarin or dabigatran for a condition other than AF
  • Subject who is on clopidogrel or another P2Y12 platelet inhibitor such as prasugrel or ticagrelor
  • Subject who has an absolute or relative contraindication to aspirin, or warfarin and dabigatran
  • Subject with a New York Heart Association (NYHA) classification equal to IV
  • Subject with an implanted or surgical repair atrial septal defect (ASD) device or patent foramen ovale (PFO) device
  • Subject with aortic or mitral valve regurgitation of grade 2+ or greater
  • Subject with left ventricular ejection fraction (LVEF) ≤30
  • Subject with mitral or aortic prosthetic valve
  • Subject with a history of hemorrhagic or aneurysmal stroke
  • Subject with a history of previous radio frequency (RF) ablation for atrial fibrillation
  • Subject with a body mass index (BMI) ≥40
  • Subject with a history of acute or recent MI, or unstable angina, or coronary artery bypass graft surgery (within 6 months)
  • Subject who is on aspirin dose therapy greater than 81mg/day at time of enrollment

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Device
AMPLATZER Cardiac Plug
Enhed: AMPLATZER Cardiac Plug
AMPLATZER Cardiac Plug is a percutaneous transcatheter device
Aktiv komparator: Optimal Medical Therapy (control)
Warfarin Dabigatran
Enhed: AMPLATZER Cardiac Plug
AMPLATZER Cardiac Plug is a percutaneous transcatheter device

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only
Tidsramme: From Randomization to Discharge Visit

An analysis comparing the rate of procedure related serious adverse events that occur in the device arm to a performance goal determined from literature reported rates for similar procedural techniques.

The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT).

However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm below. The secondary endpoint analysis requirement was removed from the protocol.
From Randomization to Discharge Visit
Long-term Safety - Device Arm Only
Tidsramme: Randomization to 2 year follow-up

All-Cause Mortality and Major Bleeds Through 2 years in device arm subjects only. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT).

However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol.
Randomization to 2 year follow-up
Effectiveness Endpoint - Device Arm Only
Tidsramme: Randomization through 2 year follow up

Occurrence of ischemic stroke and peripheral thromboembolism in the device arm. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT).

However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol.
Randomization through 2 year follow up

Samarbejdspartnere og efterforskere

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

Sponsor

Abbott Medical Devices

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.

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 (Faktiske)

26. april 2010

Primær færdiggørelse (Faktiske)

6. december 2018

Studieafslutning (Faktiske)

6. december 2018

Datoer for studieregistrering

Først indsendt

5. maj 2010

Først indsendt, der opfyldte QC-kriterier

5. maj 2010

Først opslået (Skøn)

6. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CL00921

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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 AMPLATZER Cardiac Plug

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Algeria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner