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Optisure Lead Post Approval Study

13. januar 2021 opdateret af: Abbott Medical Devices
The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1735

Kontakter og lokationer

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

Studiesteder

  • Belgien
    • Limburg
      • Genk, Limburg, Belgien, 3600
        • Ziekenhuis Oost-Limburg
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5H 3V9
        • Royal Alexandra Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QE II Health Sciences
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre
      • Scarborough, Ontario, Canada, M1B 4Z8
        • Rouge Valley Centenary
    • Quebec
      • Montreal, Quebec, Canada, H1T1C8
        • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35211
        • Baptist Medical Center Princeton
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85018
        • Phoenix Cardiovascular Research Group
    • Arkansas
      • Jonesboro, Arkansas, Forenede Stater, 72401
        • St. Bernards (formerly Cardiology Associates of Northeast Arkansas)
    • California
      • Burbank, California, Forenede Stater, 91505
        • Raymond Schaerf, MD
      • Palm Springs, California, Forenede Stater, 92262
        • Desert Heart Rhythm Consultants
      • Reseda, California, Forenede Stater, 91335
        • Cardiac Rhythm Specialists, Inc.
      • San Diego, California, Forenede Stater, 92103
        • San Diego Heart Rhythm Center (formerly San Diego Heart and Vascular Associates)
    • Florida
      • Lake Mary, Florida, Forenede Stater, 32746
        • Jorge Diaz, M.D. , P.A.
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • Northside Hospital
    • Illinois
      • Rockford, Illinois, Forenede Stater, 61107
        • Rockford Cardiology Associates
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater, 46845
        • Parkview Research Center
    • Iowa
      • West Des Moines, Iowa, Forenede Stater, 50266
        • Iowa Heart Center
    • Kentucky
      • Edgewood, Kentucky, Forenede Stater, 41017
        • St. Elizabeth Medical Center - South Unit
    • Maryland
      • Salisbury, Maryland, Forenede Stater, 21804
        • Peninsula Cardiology Associates
    • Massachusetts
      • Leominster, Massachusetts, Forenede Stater, 01453
        • Mass Heart & Rhythm
    • Michigan
      • Flint, Michigan, Forenede Stater, 48532
        • Premier Medical Clinics
      • Grand Blanc, Michigan, Forenede Stater, 48439
        • Genesys Regional Medical Center
      • Traverse City, Michigan, Forenede Stater, 49684
        • Northern Michigan Hospital
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Minneapolis Heart Institute
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216
        • Jackson Heart Clinic
      • Tupelo, Mississippi, Forenede Stater, 38801
        • Cardiology Associates of North Mississippi
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89109
        • HealthCare Partners Cardiology
    • New Jersey
      • Haddon Heights, New Jersey, Forenede Stater, 08035
        • Cardiovascular Associates of the Delaware Valley
      • Voorhees, New Jersey, Forenede Stater, 08043
        • Lourdes Cardiology Services
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87106
        • Presbyterian Heart Group
    • New York
      • Brooklyn, New York, Forenede Stater, 11219
        • Maimonides Medical Center
      • Brooklyn, New York, Forenede Stater, 11235
        • Coney Island Hospital
      • Liverpool, New York, Forenede Stater, 13088
        • Cardiovascular Group of Syracuse
    • North Carolina
      • High Point, North Carolina, Forenede Stater, 27262
        • High Point Regional Health (formerly Carolina Cardiology Cornerstone)
      • New Bern, North Carolina, Forenede Stater, 28562
        • CarolinaEast Heart Center
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • VA Medical Center Cleveland
      • Willoughby, Ohio, Forenede Stater, 44094
        • Great Lakes Medical Research, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • Integris Baptist Medical Center
    • Oregon
      • Portland, Oregon, Forenede Stater, 97225
        • Providence Heart and Vascular Institute
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18105
        • Lehigh Valley Hospital
      • Lancaster, Pennsylvania, Forenede Stater, 17602
        • Lancaster General Hospital
      • Newtown, Pennsylvania, Forenede Stater, 18940
        • Arrhythmia Institute
    • Tennessee
      • Germantown, Tennessee, Forenede Stater, 38138
        • The Stern Cardiovascular Foundation
    • Texas
      • Bedford, Texas, Forenede Stater, 76021
        • HeartPlace
      • Dallas, Texas, Forenede Stater, 75216
        • VA Medical Center Dallas
      • El Paso, Texas, Forenede Stater, 79936
        • Cardiology Care Consultants
      • Temple, Texas, Forenede Stater, 76508
        • Scott & White Memorial Hospital
    • Utah
      • Saint George, Utah, Forenede Stater, 84790
        • Heart of Dixie Cardiology (formerly Dixie Regional Medical Center - River Road Campus)
    • Virginia
      • Fredericksburg, Virginia, Forenede Stater, 22401
        • Mary Washington Hospital
      • Richmond, Virginia, Forenede Stater, 23229
        • Virginia Cardiovascular Specialists
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Aurora Medical Group
  • Japan
    • Kanto
      • Shinjuku-Ku, Kanto, Japan, 162-8666
        • Tokyo Women's Medical University
    • Osaka
      • Abeno-ku, Osaka, Japan, 545-8565
        • Osaka City University Hospital
    • Tochigi-ken
      • Shimotsuke-shi, Tochigi-ken, Japan, 329-0498
        • Jichi Medical University Hospital
  • Polen
      • Lodz, Polen
        • Mc-Tronik
  • Portugal
    • Lisbon
      • Lisboa, Lisbon, Portugal, 1649-035
        • Santa Maria Hospital
  • Tyskland
      • Bad Krozingen, Tyskland, 79189
        • Universitäts-Herzzentrum Freiburg - Bad Krozingen

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

ICD/CRT-D indicated patients

Beskrivelse

Inclusion Criteria:

Eligible patients will meet all of the following:

  1. Have an approved indication, as per ACC/AHA/HRS/ESC guidelines, for implantation of an ICD or CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
  2. Have been implanted with a St. Jude Medical Optisure lead in the last 30 days or are scheduled for an Optisure lead implant.
  3. Have the ability to provide informed consent for study participation and be 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:

Patients will be excluded if they meet any of the following:

  1. Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study.
  2. Have a life expectancy of less than 5 years 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

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead
Enhed: St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Freedom from RV Lead Related Complications
Tidsramme: Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.

Sekundære resultatmål

Resultatmål
Tidsramme
Optisure Lead-Related Complication Rates
Tidsramme: Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.

Andre resultatmål

Resultatmål
Tidsramme
Optisure Lead Related Adverse Events
Tidsramme: Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
The annual hazard rate of lead electrical dysfunction
Tidsramme: Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
The annual hazard rate of externalized conductors
Tidsramme: Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
The annual hazard rate of other visual lead anomalies by each subcategory
Tidsramme: Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
Prevalence of "other insulation anomalies" in "returned leads
Tidsramme: Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
Time from externalized conductors to electrical dysfunction
Tidsramme: Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
Time from other visual lead anomalies by each subcategory to electrical dysfunction
Tidsramme: Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
Adverse Event rate through 30 days post-intervention for lead (e.g. extraction, abandonment, revision, other)
Tidsramme: Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
Time from externalized conductors to clinical intervention
Tidsramme: Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
Time from other visual lead anomalies by each subcategory to clinical intervention
Tidsramme: Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
Comparison of patients with lead compromise as evidenced by imaging (includes externalized conductors and other visual lead anomalies) to those without lead compromise
Tidsramme: Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.
Comparison of patients with electrical dysfunction to those without electrical dysfunction.
Tidsramme: Date at which all patients have completed their five year follow-up.
Date at which all patients have completed their five year follow-up.

Samarbejdspartnere og efterforskere

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

Sponsor

Abbott Medical Devices

Efterforskere

  • Studieleder: Grant Kim, Abbott Medical Devices

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)

30. juni 2020

Studieafslutning (Faktiske)

30. juni 2020

Datoer for studieregistrering

Først indsendt

7. september 2014

Først indsendt, der opfyldte QC-kriterier

9. september 2014

Først opslået (Skøn)

10. september 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 60045220

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 St. Jude Medical Optisure Lead

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Japan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner