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QP ExCELs: MultiPole Pacing (MPP) Sub-Study

16. februar 2021 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

53

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

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:

  • 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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: MultiPole Pacing
Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.
Enhet: MultiPole Pacing
CRT non-responders are programmed with MultiPole pacing ON.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

Biotronik, Inc.

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)

19. mai 2017

Primær fullføring (Faktiske)

23. januar 2020

Studiet fullført (Faktiske)

23. januar 2020

Datoer for studieregistrering

Først innsendt

15. mai 2017

Først innsendt som oppfylte QC-kriteriene

15. mai 2017

Først lagt ut (Faktiske)

16. mai 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. februar 2021

Sist bekreftet

1. februar 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MPP Sub-Study

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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. .

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