Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

AMPLATZER Cardiac Plug Clinical Trial

2. april 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

97

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Device
AMPLATZER Cardiac Plug
Enhet: AMPLATZER Cardiac Plug
AMPLATZER Cardiac Plug is a percutaneous transcatheter device
Aktiv komparator: Optimal Medical Therapy (control)
Warfarin Dabigatran
Enhet: AMPLATZER Cardiac Plug
AMPLATZER Cardiac Plug is a percutaneous transcatheter device

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Abbott Medical Devices

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. april 2010

Primær fullføring (Faktiske)

6. desember 2018

Studiet fullført (Faktiske)

6. desember 2018

Datoer for studieregistrering

Først innsendt

5. mai 2010

Først innsendt som oppfylte QC-kriteriene

5. mai 2010

Først lagt ut (Anslag)

6. mai 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. april 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. april 2020

Sist bekreftet

1. april 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CL00921

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på AMPLATZER Cardiac Plug

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Colombia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere