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QP ExCELs: MultiPole Pacing (MPP) Sub-Study

16. februar 2021 opdateret af: Biotronik, Inc.
The objective of this MultiPole Pacing (MPP) sub-study of the QP ExCELs study is to demonstrate that the MPP feature is effective by converting a percentage of cardiac resynchronization therapy (CRT) non-responders to responders. The MPP sub-study is a single-arm, multi-center, prospective trial within the ongoing QP ExCELs study (NCT02290028).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

53

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
    • Alabama
      • Fairhope, Alabama, Forenede Stater, 36532
        • Thomas Hospital
    • California
      • Inglewood, California, Forenede Stater, 90301
        • South Bay Electrophysiology
      • Rancho Mirage, California, Forenede Stater, 92270
        • Eisenhower Desert Cardiology
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Orlando, Florida, Forenede Stater, 32803
        • Florida Hospital
      • Orlando, Florida, Forenede Stater, 32806
        • Orlando Health Heart Institute
      • Tampa, Florida, Forenede Stater, 33613
        • Florida Hospital Tampa Pepin Heart Institute
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30309
        • Piedmont Heart Institute
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago Medical Center
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater, 46845
        • Parkview Physicians Group - Cardiology
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • University of Kansas Hospital
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • University of Kentucky
      • Lexington, Kentucky, Forenede Stater, 40503
        • Baptist Health - Lexington
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
        • Northeast Cardiology
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
      • Fall River, Massachusetts, Forenede Stater, 02720
        • Southcoast Health
      • Worcester, Massachusetts, Forenede Stater, 01655
        • University of Massachusetts Medical School
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Hospital
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
      • Ypsilanti, Michigan, Forenede Stater, 48197
        • Michigan Heart
    • Mississippi
      • Tupelo, Mississippi, Forenede Stater, 38801
        • Cardiology Associates of North Mississippi
    • Missouri
      • Saint Charles, Missouri, Forenede Stater, 63301
        • SSM Health St. Joseph Hospital - St. Charles
      • Saint Louis, Missouri, Forenede Stater, 63136
        • St. Louis Heart and Vascular
      • Springfield, Missouri, Forenede Stater, 65804
        • Mercy Clinic Cardiology
    • Montana
      • Kalispell, Montana, Forenede Stater, 59901
        • Glacier View Medical Research Institute, Cardiology
    • New Jersey
      • Neptune, New Jersey, Forenede Stater, 07753
        • Jersey Shore University Medical Center
    • New York
      • Bronx, New York, Forenede Stater, 10467
        • Montefiore Medical Center
      • Flushing, New York, Forenede Stater, 11355
        • New York Presbyterian Queens
      • New York, New York, Forenede Stater, 10021
        • Weill Cornell Medicine
      • New York, New York, Forenede Stater, 10025
        • Mt. Sinai St. Luke's Hospital
      • Valhalla, New York, Forenede Stater, 10595
        • Westchester Medical Center
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28803
        • Asheville Cardiology Associates
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest Baptist Health Medical Center
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Novant Health Winston-Salem Cardiology
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58102
        • Sanford Medical Center - Fargo
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • Temple Heart and Vascular Institute
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29607
        • Upstate Cardiology
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37403
        • UT Erlanger Cardiology
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76104
        • Fort Worth Heart
      • The Woodlands, Texas, Forenede Stater, 77380
        • UT Health Science Center
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • University of Utah Medical Center
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • UVM Medical

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:

  • Currently enrolled in the ongoing QP ExCELs study
  • Successfully implanted with a BIOTRONIK Ilivia 7 HF-T QP family CRT-D system, or future-marketed CRT-D system with the MPP feature. Successful implantation is defined as having at least two LV pacing vectors with a measured pacing threshold of ≤ 5.0 V @ any pulse width (allowing for a minimum 2.5 V safety margin) without phrenic nerve stimulation at the final programmed pacing output at the time of enrollment into the MPP sub-study.
  • CRT Responder Assessment classification as "Worsened" or "Unchanged"
  • Standard continuous biventricular (BiV) pacing from implant until the 6-Month QP ExCELs follow-up visit. (Implant to 3-Month QP ExCELs follow-up who qualify due to a Heart Failure (HF) hospitalization event)
  • Able to understand the nature of the sub-study and give informed consent
  • Available for an additional follow-up visit specific to the MPP sub-study at the investigational site
  • No evidence of non-compliance to their ongoing commitment in the QP ExCELs study

Exclusion Criteria:

  • Have a life expectancy of less than 6 months
  • Expected to receive heart transplantation or ventricular assist device within 6 months
  • Chronic atrial fibrillation
  • Presence of another life-threatening, underlying illness separate from their cardiac disorder
  • Received MPP pacing prior to enrolment into the MPP sub-study

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: MultiPole Pacing
Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.
Enhed: MultiPole Pacing
CRT non-responders are programmed with MultiPole pacing ON.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cardiac Resynchronization Therapy (CRT) Responder Status With the MPP Feature
Tidsramme: Enrollment to 6 Months

Count of participants who are classified as "Improved", where responder classification is derived from a clinical composite score (CCS) based on changes in New York Heart Association (NYHA) class, Heart Failure (HF) hospitalization, and cardiovascular death.

Responder classification at 6 months (evaluated compared to MPP Enrollment Visit) :

  • "Improved"

    • No HF hospitalization or cardiovascular death, AND
    • NYHA class is improved

  • "Unchanged"

    • No HF hospitalization or cardiovascular death, AND
    • NYHA class is unchanged

  • "Worsened"

    • HF hospitalization or cardiovascular death has occurred, OR
    • NYHA class is worsened
Enrollment to 6 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Without MPP System Related Adverse Events Requiring Additional Invasive Intervention to Resolve at 6 Months.
Tidsramme: Enrollment to 6 Months
Evaluate adverse events that require additional invasive intervention to resolve specifically related to the MPP feature. These adverse events include any software issues related to MPP programming or any adverse event that occurs while MPP is enabled and that may be attributed to the use of the MPP feature. Outcome was evaluated as an adverse event free-rate (AEFR).
Enrollment to 6 Months
Clinical Composite Score (CCS) + Patient Global Assessment (PGA) Responder Status Utilizing a Modified CCS That Incorporates the PGA
Tidsramme: Enrollment to 6 Months

Evaluate a modified CCS, determining a responder classification based on changes in NYHA class, PGA, HF hospitalization, and cardiovascular death, where the PGA will ask participantss to assess how their overall status has changed since prior to receiving CRT therapy (markedly better, better, unchanged, worse, markedly worse).

Modified responder classification (CCS + PGA) at 6 months (evaluated compared to MPP Enrollment Visit):

  • "Improved"

    • No HF hospitalization or cardiovascular death, AND
    • Neither NYHA class is worsened or PGA is worsened ("worse" or "markedly worse"), AND
    • NYHA class is improved or PGA is improved ("better" or "markedly better")

  • "Unchanged"

    • No HF hospitalization or cardiovascular death, AND
    • NYHA class is unchanged, AND
    • PGA is unchanged ("unchanged")

  • "Worsened"

    • HF hospitalization or cardiovascular death has occurred, OR
    • NYHA class is worsened or PGA is worsened ("worse" or "markedly worse")
Enrollment to 6 Months
CCS Responder Status Utilizing an Expanded Responder Classification
Tidsramme: Enrollment to 6 Months

Evaluate a modified CCS with an expanded responder classification where "Improved" and "Unchanged" are considered responders.

Responder classification at 6 months (evaluated compared to MPP Enrollment Visit) :

  • "Improved"

    • No HF hospitalization or cardiovascular death, AND
    • NYHA class is improved

  • "Unchanged"

    • No HF hospitalization or cardiovascular death, AND
    • NYHA class is unchanged

  • "Worsened"

    • HF hospitalization or cardiovascular death has occurred, OR
    • NYHA class is worsened
Enrollment to 6 Months

Samarbejdspartnere og efterforskere

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

Sponsor

Biotronik, Inc.

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)

19. maj 2017

Primær færdiggørelse (Faktiske)

23. januar 2020

Studieafslutning (Faktiske)

23. januar 2020

Datoer for studieregistrering

Først indsendt

15. maj 2017

Først indsendt, der opfyldte QC-kriterier

15. maj 2017

Først opslået (Faktiske)

16. maj 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MPP Sub-Study

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

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 Hjertefejl

Kliniske forsøg med MultiPole Pacing

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Thailand

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner