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Personalized CRT - MPP Post Approval Study

15. februar 2021 oppdatert av: Medtronic

Personalized CRT - Multiple Point Pacing Post Approval Study

The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Medtronic market-released cardiac resynchronization therapy (CRT) Quadripolar (Quad) systems approved for commercial release with the Multiple Point Pacing (MPP) feature were eligible to contribute to the Post-Approval Study (PAS) objectives. Products with MPP capabilities receiving appropriate license or regulatory approval during the conduct of the PAS were included and contributed to the PAS objectives upon commercial release. CRT is an established pacing therapy for patients with heart failure (HF). CRT provides atrial- synchronized biventricular (BiV) pacing using standard pacing technology combined with a special third lead that is implanted via the coronary sinus and positioned in a cardiac vein to sense and/or pace the left ventricle (LV). Following a sensed atrial contraction or atrial paced event, both ventricles are stimulated to synchronize their contraction. The MPP feature is designed to allow a second LV pace to occur in LV Only or BiV pace configurations. In the LV Only pace configuration, the LV paces occur simultaneously or sequentially (LV- LV), as applicable by product. When Bi-V pacing is enabled, the RV pace can be delivered either before or after the LV paces, with the order determined by the programmed Ventricular Pacing Configuration.

The MPP PAS was a global, prospective, observational multi-center study. Patients implanted with an eligible CRT Quad system were enrolled and followed in the Product Surveillance Registry per the expected standard of care practices of their care provider.

Studietype

Observasjonsmessig

Registrering (Faktiske)

1338

Kontakter og plasseringer

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

Studiesteder

  • Belgia
      • Leuven, Belgia, 3000
        • UZ Leuven - Campus Gasthuisberg
      • Yvoir, Belgia, 5530
        • CHU UCL Mont-Godinne - Dinant
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
      • Québec, Quebec, Canada, G1V 4G5
        • Institut de cardiologie et de pneumologie de Québec (IUCPQ)
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294-0001
        • University of Alabama at Birmingham
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72205-6202
        • Saint Vincent Heart Clinic Arkansas
    • California
      • Chula Vista, California, Forente stater, 91910
        • Chula Vista Cardiac Center
      • Palm Springs, California, Forente stater, 92262
        • Desert Heart Rhythm Consultants
      • Torrance, California, Forente stater, 90505
        • COR Healthcare
    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80907
        • Colorado Springs Cardiology
      • Denver, Colorado, Forente stater, 80204
        • Denver Heart
      • Lakewood, Colorado, Forente stater, 80228
        • Colorado Heart and Vascular, PC
    • Florida
      • Hollywood, Florida, Forente stater, 33021
        • Heart Rhythm Solutions
      • Jacksonville, Florida, Forente stater, 32207
        • Baptist Health
      • Safety Harbor, Florida, Forente stater, 34695-6604
        • Heart & Vascular Institute of Florida
    • Georgia
      • Albany, Georgia, Forente stater, 31701
        • Phoebe Putney Memorial Hospital
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160-8500
        • The University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, Forente stater, 21237-3958
        • MedStar Health Research Institute
      • Bethesda, Maryland, Forente stater, 20817
        • The Johns Hopkins Hospital
      • Salisbury, Maryland, Forente stater, 21804-6938
        • Delmarva Heart Research Foundation Inc
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Forente stater, 02114-2621
        • Massachusetts General Hospital
    • Michigan
      • Marquette, Michigan, Forente stater, 49855-2705
        • UP Health System - Marquette
      • Ypsilanti, Michigan, Forente stater, 48197-8633
        • Michigan Heart
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55407-1157
        • Minneapolis Heart Institute Foundation
      • Robbinsdale, Minnesota, Forente stater, 55422
        • North Memorial Heart and Vascular Institute
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic
    • Missouri
      • Columbia, Missouri, Forente stater, 65201-8023
        • Missouri Cardiovascular Specialists
      • Saint Louis, Missouri, Forente stater, 63110-1010
        • Washington University School of Medicine
    • Nevada
      • Henderson, Nevada, Forente stater, 89052-4171
        • HealthCare Partners Medical Group
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87106-4921
        • Presbyterian Heart Group
    • New York
      • Garden City, New York, Forente stater, 11530-1613
        • Island Cardiac Specialists
      • Huntington, New York, Forente stater, 11743-2787
        • Huntington Hospital
      • Manhasset, New York, Forente stater, 11030
        • Northwell Health
      • Poughkeepsie, New York, Forente stater, 12601-3923
        • Hudson Valley Heart Center
      • Utica, New York, Forente stater, 13501-5930
        • Central New York Cardiology
    • North Carolina
      • Raleigh, North Carolina, Forente stater, 27610
        • WakeMed Health & Hospitals
    • Ohio
      • Akron, Ohio, Forente stater, 44304-1473
        • Northeast Ohio Cardiovascular Specialists
      • Cincinnati, Ohio, Forente stater, 45267-0542
        • University of Cincinnati
      • Cincinnati, Ohio, Forente stater, 45219
        • The Christ Hospital Health Network
      • Toledo, Ohio, Forente stater, 43608
        • Mercy Health - Saint Vincent Medical Center
    • Oklahoma
      • Cleveland, Oklahoma, Forente stater, 44195-0001
        • Cleveland Clinic
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18103-6381
        • Lehigh Valley Health Network
      • Danville, Pennsylvania, Forente stater, 17822
        • Geisinger Medical Center
      • Wilkes-Barre, Pennsylvania, Forente stater, 18711
        • Geisinger Wyoming Valley Medical Center
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37205-2018
        • Saint Thomas Research Institute
    • Texas
      • Austin, Texas, Forente stater, 78705-1852
        • Texas Cardiac Arrhythmia Research Foundation
    • Vermont
      • Burlington, Vermont, Forente stater, 05401
        • The University of Vermont Medical Center
    • Washington
      • Spokane, Washington, Forente stater, 99204-2352
        • Kootenai Heart Clinics Northwest
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53215
        • Aurora Cardiovascular Services
  • Frankrike
      • Brest, Frankrike, 29609
        • CHRU Brest - Hôpital de la Cavale Blanche
      • Clermont-Ferrand, Frankrike, 63003
        • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
      • La Rochelle, Frankrike, 17019
        • CHRU La Rochelle
      • Montpellier, Frankrike, 34295
        • CHU de Montpellier - Hôpital Arnaud de Villeneuve
      • Nantes, Frankrike, 44277
        • Nouvelles Cliniques Nantaises
      • Pringy, Frankrike, 74374
        • Centre hospitalier de la région d'Annecy
  • Italia
      • Milano, Italia, 20162
        • Azienda Ospedaliera Ospedale Niguarda Ca Granda
  • Korea, Republikken
      • Seoul, Korea, Republikken, 135-710
        • Samsung Medical Center
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Institut Jantung Negara - National Heart Institute
  • Nederland
      • Maastricht, Nederland, 6229 HX
        • Maastricht Universitair Medisch Centrum
      • Rotterdam, Nederland, 3079 DZ
        • Maasstad Hospital Rotterdam
  • Slovakia
      • Kosice, Slovakia, 04011
        • Východoslovenský Ústav Srdcových A Cievnych Chorôb, A.S.
  • Spania
      • A Coruña, Spania, 15006
        • Hospital Universitario da Coruna
      • Madrid, Spania, 28007
        • Hospital General Universitario Gregorio Marañon
      • Palma de Mallorca, Spania, 07210
        • Hospital Universitario Son Espases
      • Santiago de Compostela, Spania, 15706
        • Complejo Hospitalario Universitario de Santiago de Compostela
  • Storbritannia
      • Birmingham, Storbritannia, B15 2GW
        • University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
      • Leicester, Storbritannia, LE3 9QP
        • Glenfield Hospital
      • Liverpool, Storbritannia, L14 3PE
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
      • Manchester, Storbritannia, M13 9WL
        • Central Manchester University Hospitals NHS - Manchester Royal Infirmary
      • Middlesbrough, Storbritannia, TS4 3BW
        • The James Cook University Hospital - South Tees Hospitals NHS
  • Tyskland
      • Aachen, Tyskland, 52074
        • Universitätsklinikum Aachen, AöR
      • Essen, Tyskland, 045147
        • Universitatsklinikum Essen
      • Homburg, Tyskland, 66421
        • Universitätsklinikum des Saarlandes
      • Köln, Tyskland, 50733
        • St. Vinzenz-Hospital Köln
      • Tübingen, Tyskland, 72076
        • Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
      • Ulm, Tyskland, 89081
        • Universitatsklinikum Ulm
  • Ungarn
      • Budapest, Ungarn, 1134
        • 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

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The study population includes patients that are or will be implanted with an eligible CRT Quad system.

Beskrivelse

Inclusion Criteria:

  • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Patient has or is intended to receive or be treated with an eligible CRT device
  • Patient within 30 days of therapy received at the time of their initial PSR platform enrollment

Exclusion Criteria:

  • Patient who is, or is expected to be inaccessible for follow-up
  • Patient with exclusion criteria required by local law
  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
CRT non-responders with MPP enabled
Patients enrolled and implanted with a CRT Quad system, who are identified as CRT non-responder, for which MPP is enabled.
Enhet: Cardiac Resynchronization Therapy - MPP
The multiple point pacing feature (MPP) is designed to allow pacing from 2 LV electrodes.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
MPP therapy responder
Tidsramme: Up to 3 years
To estimate the proportion of MPP therapy responders among patients who did not respond to standard CRT and had MPP programmed "on".
Up to 3 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
HF hospitalization and/or mortality
Tidsramme: Up to 3 years
Summarize incidence of HF hospitalization and/or mortality probability after MPP enabled
Up to 3 years

Samarbeidspartnere og etterforskere

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

Sponsor

Medtronic

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)

5. juli 2017

Primær fullføring (Faktiske)

4. juni 2020

Studiet fullført (Faktiske)

7. januar 2021

Datoer for studieregistrering

Først innsendt

26. juli 2017

Først innsendt som oppfylte QC-kriteriene

26. juli 2017

Først lagt ut (Faktiske)

28. juli 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. februar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. februar 2021

Sist bekreftet

1. februar 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MPP PAS

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

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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Kliniske studier på Cardiac Resynchronization Therapy - MPP

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in India

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

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Steder

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