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Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study

31. januar 2019 opdateret af: Abbott Medical Devices

A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an IDE Study

The primary intent of this study is to assess the safety of the model 1457Q Quartet LV lead at 3 months in a patient population indicated for cardiac resynchronization therapy.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a prospective, multi-center, IDE clinical study designed to evaluate the safety of the Model 1457Q Quartet LV lead.

A minimum of 94 and a maximum of 430 subjects will be enrolled in this study at up to 40 centers worldwide.

All subjects successfully implanted with a Quartet 1457Q lead will be followed every 6 months post implant until Pre Market Approval (PMA) is obtained or the study is closed.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

499

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
      • Huntsville, Alabama, Forenede Stater, 35801
        • Heart Center Research
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85013
        • Arizona Arrhythmia Research Center
    • Arkansas
      • Jonesboro, Arkansas, Forenede Stater, 72401
        • Cardiology Associates of Northeast Arkansas
    • California
      • La Jolla, California, Forenede Stater, 92037
        • Scripps Health
      • Newport Beach, California, Forenede Stater, 92663
        • Premier Cardiology, Inc.
      • Stanford, California, Forenede Stater, 94305
        • Stanford University Hospital
    • Florida
      • Ocala, Florida, Forenede Stater, 34471
        • Munroe Regional Medical Center
      • Tallahassee, Florida, Forenede Stater, 32308
        • Tallahassee Research Institute
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University Hospital
      • Gainesville, Georgia, Forenede Stater, 30501
        • North Georgia Heart Foundation
    • Iowa
      • West Des Moines, Iowa, Forenede Stater, 50266
        • Iowa Heart Center
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40503
        • Central Baptist Hospital
      • Owensboro, Kentucky, Forenede Stater, 42304
        • One Health Cardiology
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
    • Michigan
      • Lansing, Michigan, Forenede Stater, 48912
        • Thoracic Cardiovascular Healthcare Foundation
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65201
        • Missouri Heart Center
    • New Hampshire
      • Manchester, New Hampshire, Forenede Stater, 03102
        • Catholic Medical Center
    • New Jersey
      • Haddon Heights, New Jersey, Forenede Stater, 08035
        • Cardiovascular Associates of Delaware Valley
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Forsyth Medical Center
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • University Hospitals of Cleveland
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74104
        • Oklahoma Heart Institute at Utica
    • Pennsylvania
      • Lancaster, Pennsylvania, Forenede Stater, 17602
        • Lancaster General Hospital
      • Sayre, Pennsylvania, Forenede Stater, 18840
        • Donald Guthrie Foundation for Education & Research
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29605
        • Greenville Health System
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37403
        • Erlanger Medical Center
      • Germantown, Tennessee, Forenede Stater, 38138
        • The Stern Cardiovascular Foundation
    • Texas
      • Plano, Texas, Forenede Stater, 75093
        • The Heart Hospital Baylor Plano
    • Washington
      • Seattle, Washington, Forenede Stater, 98122
        • Swedish Medical Center - Heart & Vascular
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53715
        • St. Mary's Hospital

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:

  1. Meets current St. Jude Medical clinical indication for implantation of a cardiac resynchronization therapy system:

    " to provide a reduction of the symptoms of moderate to severe heart failure (New York Heart Association Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration, OR " to maintain synchrony of the left and right ventricles in patients who have undergone an Atrio Ventricular nodal ablation for chronic (permanent) atrial fibrillation and have New York Heart Association Functional Class II or III heart failure.

  2. Is receiving a new market-approved St. Jude Medical quadripolar cardiac resynchronization therapy system implant with the Quartet 1457Q LV lead.
  3. Have the ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
  4. Are 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

  1. Had a previous unsuccessful commercial or non-Quartet 1457Q LV lead implant attempt
  2. Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
  3. Patient is currently participating or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in other studies may be allowed if pre-approval is granted from the study manager.
  4. Are pregnant or planning pregnancy in the next 6 months
  5. Have a life expectancy of less than 24 months due to any condition

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: Treatment
Subjects implanted with the Quartet 1457Q LV lead
Enhed: Quartet 1457Q LV Lead

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Patients Free From LV Lead-related Complications Through 3 Months
Tidsramme: 3 months
A complication is defined as a Serious Adverse Device Effect related to the Quartet 1457Q lead. A Serious Adverse Device Effect is an event related to the use of a medical device that led to death, a life-threatening illness or injury, a permanent impairment to a body structure or a body function, an in-patient or prolonged hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body, a malignant tumor OR fetal distress, fetal death or a congenital abnormality or birth defect.
3 months

Samarbejdspartnere og efterforskere

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

Sponsor

Abbott Medical Devices

Efterforskere

  • Studiestol: David Delurgio, MD, Emory University

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)

27. oktober 2015

Primær færdiggørelse (Faktiske)

19. august 2016

Studieafslutning (Faktiske)

21. marts 2017

Datoer for studieregistrering

Først indsendt

10. september 2015

Først indsendt, der opfyldte QC-kriterier

10. september 2015

Først opslået (Skøn)

14. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CRD 616

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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 Quartet 1457Q LV Lead

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Pakistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner