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Attain Performa™ Left Ventricular (LV) Quadripolar Leads Chronic Performance Study

28. januar 2022 opdateret af: Medtronic

Attain Performa™ Left Ventricular Quadripolar Lead Post-Approval Study

Lead survivability will be summarized.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

The purpose of this study is to evaluate long-term performance of the Attain Performa™ LV Leads. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Attain Performa™ LV Leads. This study is conducted within Medtronic's post-market surveillance platform.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1900

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Leuven, Belgien
  • Canada
      • Calgary, Canada
      • Ottawa, Canada
      • Quebec, Canada
    • Alberta
      • Calgary, Alberta, Canada
    • Ontario
      • London, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Det Forenede Kongerige
      • Liverpool, Det Forenede Kongerige
      • Middlesbrough, Det Forenede Kongerige
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85226
      • Gilbert, Arizona, Forenede Stater, 85295
    • Arkansas
      • Jonesboro, Arkansas, Forenede Stater, 72410
    • California
      • Bakersfield, California, Forenede Stater, 93301
      • Rancho Mirage, California, Forenede Stater, 92270
      • Redwood City, California, Forenede Stater, 94062
      • Salinas, California, Forenede Stater, 93901
      • San Diego, California, Forenede Stater, 92103
      • Stanford, California, Forenede Stater, 94305
      • Torrance, California, Forenede Stater, 90503
      • Van Nuys, California, Forenede Stater, 91405
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80907
      • Lakewood, Colorado, Forenede Stater, 80228
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06519
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010
    • Florida
      • Bradenton, Florida, Forenede Stater, 34205
      • Clearwater, Florida, Forenede Stater, 33756
      • Jacksonville, Florida, Forenede Stater, 32216
      • Safety Harbor, Florida, Forenede Stater, 34695
    • Georgia
      • Albany, Georgia, Forenede Stater, 31701
      • Marietta, Georgia, Forenede Stater, 30060
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47710
    • Iowa
      • West Des Moines, Iowa, Forenede Stater, 50266
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
    • Kentucky
      • Edgewood, Kentucky, Forenede Stater, 41017
      • Lexington, Kentucky, Forenede Stater, 40503
      • Louisville, Kentucky, Forenede Stater, 40207
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70808
    • Maryland
      • Hyattsville, Maryland, Forenede Stater, 20782
      • Salisbury, Maryland, Forenede Stater, 21804
      • Silver Spring, Maryland, Forenede Stater, 20910
      • Takoma Park, Maryland, Forenede Stater, 20912
    • Michigan
      • Lansing, Michigan, Forenede Stater, 48912
      • Marquette, Michigan, Forenede Stater, 49855
      • Ypsilanti, Michigan, Forenede Stater, 48197
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55407
      • Robbinsdale, Minnesota, Forenede Stater, 55422
      • Rochester, Minnesota, Forenede Stater, 554905
    • Mississippi
      • Hattiesburg, Mississippi, Forenede Stater
        • Hattiesburg Clinic
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65201
      • Kansas City, Missouri, Forenede Stater, 64111
      • Saint Louis, Missouri, Forenede Stater, 63110
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89169
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03766
    • New Jersey
      • Morristown, New Jersey, Forenede Stater, 07960
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87106
    • New York
      • Huntington, New York, Forenede Stater, 11743
      • New York, New York, Forenede Stater, 10032
      • Poughkeepsie, New York, Forenede Stater, 12601
      • Utica, New York, Forenede Stater, 13501
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28203
      • Durham, North Carolina, Forenede Stater, 27705
      • Raleigh, North Carolina, Forenede Stater, 27610
    • Ohio
      • Akron, Ohio, Forenede Stater, 44304
      • Cincinnati, Ohio, Forenede Stater, 45219
      • Cleveland, Ohio, Forenede Stater, 44195
      • Toledo, Ohio, Forenede Stater, 43608
    • Oregon
      • Portland, Oregon, Forenede Stater, 97220
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
      • Bethlehem, Pennsylvania, Forenede Stater
        • St Luke's University Health Network
      • Danville, Pennsylvania, Forenede Stater, 17822
      • Erie, Pennsylvania, Forenede Stater, 16550
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
      • Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
    • Tennessee
      • Germantown, Tennessee, Forenede Stater, 38138
      • Nashville, Tennessee, Forenede Stater, 37203
    • Texas
      • Austin, Texas, Forenede Stater, 78705
      • Dallas, Texas, Forenede Stater, 75226
      • Fort Worth, Texas, Forenede Stater, 76104
      • Houston, Texas, Forenede Stater, 77030
      • Plano, Texas, Forenede Stater, 75093
      • The Woodlands, Texas, Forenede Stater, 77384
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
    • Virginia
      • Falls Church, Virginia, Forenede Stater, 22042
      • Leesburg, Virginia, Forenede Stater, 20176
    • Washington
      • Spokane, Washington, Forenede Stater, 99204
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53715
      • Milwaukee, Wisconsin, Forenede Stater, 53215
  • Frankrig
      • La Rochelle, Frankrig
      • Nantes, Frankrig
  • Holland
      • Eindhoven, Holland
      • Maastricht, Holland
      • Nieuwegein, Holland
      • Rotterdam, Holland
  • Schweiz
      • Zurich, Schweiz
  • Tyskland
      • Essen, Tyskland
      • Hannover, Tyskland
      • Ulm, Tyskland

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

Patients implanted with an Attain Performa™ LV Lead within 30 days. All subjects must meet Inclusion criteria and none of the Exclusion criteria.

Beskrivelse

Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.

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 an Attain Performa™ LV lead
  • Patient within 30 day post implant enrollment window

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
Attain Performa™ LV Leads
Patients who meet all Inclusion criteria and no Exclusion criteria and are implanted with an Attain Performa™ LV lead.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lead complication
Tidsramme: 5 years

Survival analysis will be used to analyze the lead. Lead status will be reported as a function of time post-implant for all leads in the study.

Lead related complications include but are not limited to: failure to capture, abnormal sensing, threshold rise, abnormal impedance, insulation breach, conductor fracture, extracardiac stimulation, lead dislodgement, cardiac perforation, structural lead failure.
5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Types of lead-related adverse device effects
Tidsramme: 5 years
Summary statistics will be used to report types and rates of lead related adverse device effects (ADE). Examples of ADEs include but are not limited to: failure to capture, abnormal sensing, threshold rise, abnormal impedance, insulation breach, conductor fracture, extracardiac stimulation, lead dislodgement, cardiac perforation, structural lead failure.
5 years
Returned lead analysis
Tidsramme: 5 years
A listing of analysis results of all Attain Performa study leads which are explanted and returned for analysis will be reported.
5 years
Lead survival estimate by model
Tidsramme: 5 years
An analysis will be conducted at the end of the study to provide comparative statistics on the safety performance of each individual lead model.
5 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)

1. august 2014

Primær færdiggørelse (Faktiske)

31. juli 2021

Studieafslutning (Faktiske)

31. juli 2021

Datoer for studieregistrering

Først indsendt

8. oktober 2014

Først indsendt, der opfyldte QC-kriterier

14. november 2014

Først opslået (Skøn)

19. november 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. januar 2022

Sidst verificeret

1. januar 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Attain Performa™ PAS

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

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Zimbabwe

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner