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Cardiac Resynchronization Therapy Efficacy Enhancements (CRTee)

8. november 2016 opdateret af: Medtronic Cardiac Rhythm and Heart Failure
The purpose of this study is to demonstrate that the amount of effective CRT (Cardiac Resynchronization Therapy) pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF Response Plus) is applied is not inferior to the amount of effective CRT pacing during AF when CAFR (Conducted AF Response) is applied.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The CRTee study is an IDE, prospective, multi-center, randomized, controlled, crossover clinical study, conducted worldwide and designed to demonstrate that the amount of effective CRT pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF Response Plus) is applied is not inferior to the amount of effective CRT pacing during AF when CAFR (Conducted AF Response) is applied.

The study will be conducted at up to 30 centers located in the United States, Europe and Middle East and Africa (MEA).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

71

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Det Forenede Kongerige
      • Liverpool, Det Forenede Kongerige
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
      • Newcastle Upon Tyne, Det Forenede Kongerige
        • he Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
  • Forenede Stater
    • Florida
      • Boca Raton, Florida, Forenede Stater
        • Cardiac Arrythmia Services
    • Iowa
      • West Des Moines, Iowa, Forenede Stater
        • Iowa Heart Center
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater
        • North Memorial Heart and Vascular
      • St. Cloud, Minnesota, Forenede Stater
        • CentraCare
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater
        • North Carolina Heart and Vascular
    • Ohio
      • Columbus, Ohio, Forenede Stater
        • Mount Carmel
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
        • Oklahoma Heart
    • Pennsylvania
      • Reading, Pennsylvania, Forenede Stater
        • Berks Cardiology
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Texas Cardiac Arrhythmia Services
    • Washington
      • Spokane, Washington, Forenede Stater
        • Kootenai Heart Clinics
  • Italien
      • Roma, Italien
        • Policlinico Universitario Agostino Gemelli
      • Seriate, Italien
        • Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
      • Tricase, Italien
        • Azienda Ospedaliera Cardinale Panico
  • Saudi Arabien
      • Riyadh, Saudi Arabien
        • Prince Sultan Cardiac Center
  • Slovakiet
      • Kosice, Slovakiet
        • Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
  • Sydafrika
      • Cape Town, Sydafrika
        • Mediclinic Panorama
  • Ungarn
      • Budapest, Ungarn
        • Magyar Honvédség Honvédkorház

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 is willing to sign and date the study patient Informed Consent form.
  • Subject is at least 18 years of age (or older, if required by local law).
  • Subject is expected to remain available after enrollment to complete follow-up visits in both arms of the study
  • Subject has had a Medtronic Viva or Brava CRT-D device implanted at least 30 days prior to enrollment.
  • Subject has history of AF burden, of at least 6 days of at least 4 hours of AF over any 4 week period within the last 90 days as documented in device diagnostic data OR if subject has no atrial lead (therefore no device diagnostic data) but clinical evidence of high AF burden.
  • Subject has demonstrated history of being able to complete Left Ventricular Capture Management (LVCM) documented in device data.
  • Subject has a documented % V pacing during AF of less than or equal to 97% within 90 days prior to enrollment or within 10 days after enrollment.

Exclusion Criteria:

  • Subject has undergone AV node ablation for treatment of AF.
  • Subject has complete or 3rd degree AV block.
  • Subject has had an MI within 30 days.
  • Subject has medical conditions that limit study participation (per physician discretion).
  • Subject is enrolled in one or more concurrent studies that could confound the study results as determined by Medtronic.
  • Subject has a limited life expectancy for non-cardiac causes that would not allow completion of the study.
  • Subject is pregnant (in the US, all women of child-bearing potential must undergo a pregnancy test within seven days prior to CRTee download).
  • Subject meets the exclusion criteria required by local law.

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: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Group A: CAFR first
Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.
Enhed: Conducted AF Response (CAFR)
The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Enhed: Conducted AF Response Plus (CAFRPlus)
The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing.
Andet: Group B: CAFRPlus first
Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.
Enhed: Conducted AF Response (CAFR)
The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
Enhed: Conducted AF Response Plus (CAFRPlus)
The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Effective CRT Pacing During AF (Non-inferiority Test)
Tidsramme: Up to 4 months
The primary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is not inferior to when CAFR is applied (non-inferiority test).
Up to 4 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Effective CRT Pacing During AF (Superiority Test)
Tidsramme: Up to 4 months
The secondary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is greater than when CAFR is applied (superiority test).
Up to 4 months

Samarbejdspartnere og efterforskere

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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Efterforskere

  • Ledende efterforsker: Suneet Mittal, MD, Valley Health System

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

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 (Faktiske)

1. januar 2016

Studieafslutning (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først indsendt

19. august 2014

Først indsendt, der opfyldte QC-kriterier

20. august 2014

Først opslået (Skøn)

21. august 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. november 2016

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CRTee

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 Atrieflimren

Kliniske forsøg med Conducted AF Response (CAFR)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Austria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner