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Personalized CRT - MPP Post Approval Study

15. februar 2021 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1338

Kontakter og lokationer

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

Studiesteder

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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.
Enhed: Cardiac Resynchronization Therapy - MPP
The multiple point pacing feature (MPP) is designed to allow pacing from 2 LV electrodes.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Medtronic

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)

5. juli 2017

Primær færdiggørelse (Faktiske)

4. juni 2020

Studieafslutning (Faktiske)

7. januar 2021

Datoer for studieregistrering

Først indsendt

26. juli 2017

Først indsendt, der opfyldte QC-kriterier

26. juli 2017

Først opslået (Faktiske)

28. juli 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MPP PAS

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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 Cardiac Resynchronization Therapy - MPP

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Rwanda

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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