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Cardiac Resynchronization Therapy Efficacy Enhancements (CRTee)

8. november 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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).

Studietype

Intervensjonell

Registrering (Faktiske)

71

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
    • Florida
      • Boca Raton, Florida, Forente stater
        • Cardiac Arrythmia Services
    • Iowa
      • West Des Moines, Iowa, Forente stater
        • Iowa Heart Center
    • Minnesota
      • Minneapolis, Minnesota, Forente stater
        • North Memorial Heart and Vascular
      • St. Cloud, Minnesota, Forente stater
        • CentraCare
    • North Carolina
      • Raleigh, North Carolina, Forente stater
        • North Carolina Heart and Vascular
    • Ohio
      • Columbus, Ohio, Forente stater
        • Mount Carmel
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater
        • Oklahoma Heart
    • Pennsylvania
      • Reading, Pennsylvania, Forente stater
        • Berks Cardiology
    • Texas
      • Austin, Texas, Forente stater, 78705
        • Texas Cardiac Arrhythmia Services
    • Washington
      • Spokane, Washington, Forente stater
        • Kootenai Heart Clinics
  • Italia
      • Roma, Italia
        • Policlinico Universitario Agostino Gemelli
      • Seriate, Italia
        • Azienda Ospedaliera Bolognini Seriate - Ospedale Bolognini
      • Tricase, Italia
        • Azienda Ospedaliera Cardinale Panico
  • Saudi-Arabia
      • Riyadh, Saudi-Arabia
        • Prince Sultan Cardiac Center
  • Slovakia
      • Kosice, Slovakia
        • Východoslovenský Ústav Srdcových A Cievnych Chorôb, A.S.
  • Storbritannia
      • Liverpool, Storbritannia
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
      • Newcastle Upon Tyne, Storbritannia
        • he Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
  • Sør-Afrika
      • Cape Town, Sør-Afrika
        • Mediclinic Panorama
  • Ungarn
      • Budapest, Ungarn
        • Magyar Honvédség Honvédkorház

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 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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Group A: CAFR first
Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.
Enhet: 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.
Enhet: 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.
Annen: Group B: CAFRPlus first
Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.
Enhet: 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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Etterforskere

  • Hovedetterforsker: Suneet Mittal, MD, Valley Health System

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.

Generelle publikasjoner

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

1. oktober 2014

Primær fullføring (Faktiske)

1. januar 2016

Studiet fullført (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først innsendt

19. august 2014

Først innsendt som oppfylte QC-kriteriene

20. august 2014

Først lagt ut (Anslag)

21. august 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. januar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. november 2016

Sist bekreftet

1. november 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CRTee

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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