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Optisure Lead Post Approval Study

13. januar 2021 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

1735

Kontakter og plasseringer

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

Studiesteder

  • Belgia
    • Limburg
      • Genk, Limburg, Belgia, 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.)
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35211
        • Baptist Medical Center Princeton
    • Arizona
      • Phoenix, Arizona, Forente stater, 85018
        • Phoenix Cardiovascular Research Group
    • Arkansas
      • Jonesboro, Arkansas, Forente stater, 72401
        • St. Bernards (formerly Cardiology Associates of Northeast Arkansas)
    • California
      • Burbank, California, Forente stater, 91505
        • Raymond Schaerf, MD
      • Palm Springs, California, Forente stater, 92262
        • Desert Heart Rhythm Consultants
      • Reseda, California, Forente stater, 91335
        • Cardiac Rhythm Specialists, Inc.
      • San Diego, California, Forente stater, 92103
        • San Diego Heart Rhythm Center (formerly San Diego Heart and Vascular Associates)
    • Florida
      • Lake Mary, Florida, Forente stater, 32746
        • Jorge Diaz, M.D. , P.A.
    • Georgia
      • Atlanta, Georgia, Forente stater, 30342
        • Northside Hospital
    • Illinois
      • Rockford, Illinois, Forente stater, 61107
        • Rockford Cardiology Associates
    • Indiana
      • Fort Wayne, Indiana, Forente stater, 46845
        • Parkview Research Center
    • Iowa
      • West Des Moines, Iowa, Forente stater, 50266
        • Iowa Heart Center
    • Kentucky
      • Edgewood, Kentucky, Forente stater, 41017
        • St. Elizabeth Medical Center - South Unit
    • Maryland
      • Salisbury, Maryland, Forente stater, 21804
        • Peninsula Cardiology Associates
    • Massachusetts
      • Leominster, Massachusetts, Forente stater, 01453
        • Mass Heart & Rhythm
    • Michigan
      • Flint, Michigan, Forente stater, 48532
        • Premier Medical Clinics
      • Grand Blanc, Michigan, Forente stater, 48439
        • Genesys Regional Medical Center
      • Traverse City, Michigan, Forente stater, 49684
        • Northern Michigan Hospital
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55407
        • Minneapolis Heart Institute
    • Mississippi
      • Jackson, Mississippi, Forente stater, 39216
        • Jackson Heart Clinic
      • Tupelo, Mississippi, Forente stater, 38801
        • Cardiology Associates of North Mississippi
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89109
        • HealthCare Partners Cardiology
    • New Jersey
      • Haddon Heights, New Jersey, Forente stater, 08035
        • Cardiovascular Associates of the Delaware Valley
      • Voorhees, New Jersey, Forente stater, 08043
        • Lourdes Cardiology Services
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87106
        • Presbyterian Heart Group
    • New York
      • Brooklyn, New York, Forente stater, 11219
        • Maimonides Medical Center
      • Brooklyn, New York, Forente stater, 11235
        • Coney Island Hospital
      • Liverpool, New York, Forente stater, 13088
        • Cardiovascular Group of Syracuse
    • North Carolina
      • High Point, North Carolina, Forente stater, 27262
        • High Point Regional Health (formerly Carolina Cardiology Cornerstone)
      • New Bern, North Carolina, Forente stater, 28562
        • CarolinaEast Heart Center
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106
        • VA Medical Center Cleveland
      • Willoughby, Ohio, Forente stater, 44094
        • Great Lakes Medical Research, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73112
        • Integris Baptist Medical Center
    • Oregon
      • Portland, Oregon, Forente stater, 97225
        • Providence Heart and Vascular Institute
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18105
        • LeHigh Valley Hospital
      • Lancaster, Pennsylvania, Forente stater, 17602
        • Lancaster General Hospital
      • Newtown, Pennsylvania, Forente stater, 18940
        • Arrhythmia Institute
    • Tennessee
      • Germantown, Tennessee, Forente stater, 38138
        • The Stern Cardiovascular Foundation
    • Texas
      • Bedford, Texas, Forente stater, 76021
        • HeartPlace
      • Dallas, Texas, Forente stater, 75216
        • VA Medical Center Dallas
      • El Paso, Texas, Forente stater, 79936
        • Cardiology Care Consultants
      • Temple, Texas, Forente stater, 76508
        • Scott & White Memorial Hospital
    • Utah
      • Saint George, Utah, Forente stater, 84790
        • Heart of Dixie Cardiology (formerly Dixie Regional Medical Center - River Road Campus)
    • Virginia
      • Fredericksburg, Virginia, Forente stater, 22401
        • Mary Washington Hospital
      • Richmond, Virginia, Forente stater, 23229
        • Virginia Cardiovascular Specialists
    • Wisconsin
      • Milwaukee, Wisconsin, Forente 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

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

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
St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead
Enhet: St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead

Hva måler studien?

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.

Samarbeidspartnere og etterforskere

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

Sponsor

Abbott Medical Devices

Etterforskere

  • Studieleder: Grant Kim, Abbott Medical Devices

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)

1. august 2014

Primær fullføring (Faktiske)

30. juni 2020

Studiet fullført (Faktiske)

30. juni 2020

Datoer for studieregistrering

Først innsendt

7. september 2014

Først innsendt som oppfylte QC-kriteriene

9. september 2014

Først lagt ut (Anslag)

10. september 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. januar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. januar 2021

Sist bekreftet

1. januar 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 60045220

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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 St. Jude Medical Optisure Lead

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

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CROs in Congo

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

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