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Protego DF4 Post Approval Registry

8. juni 2020 opdateret af: Biotronik, Inc.
The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular lead.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1694

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Gadsden, Alabama, Forenede Stater
    • Arizona
      • Avondale, Arizona, Forenede Stater
      • Glendale, Arizona, Forenede Stater
      • Peoria, Arizona, Forenede Stater
      • Phoenix, Arizona, Forenede Stater
    • California
      • Escondido, California, Forenede Stater
      • Fountain Valley, California, Forenede Stater
      • Hawthorne, California, Forenede Stater
      • Los Angeles, California, Forenede Stater
      • Santa Barbara, California, Forenede Stater
      • Temecula, California, Forenede Stater
      • Torrance, California, Forenede Stater
    • Connecticut
      • Norwalk, Connecticut, Forenede Stater
    • Florida
      • Brooksville, Florida, Forenede Stater
      • Daytona Beach, Florida, Forenede Stater
      • Kissimmee, Florida, Forenede Stater
      • Miami, Florida, Forenede Stater
      • New Smyrna Beach, Florida, Forenede Stater
      • Orlando, Florida, Forenede Stater
      • Saint Petersburg, Florida, Forenede Stater
      • Winter Park, Florida, Forenede Stater
      • Zephyrhills, Florida, Forenede Stater
    • Illinois
      • Alton, Illinois, Forenede Stater
      • Aurora, Illinois, Forenede Stater
      • Chicago, Illinois, Forenede Stater
      • Schaumburg, Illinois, Forenede Stater
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater
    • Kentucky
      • Lexington, Kentucky, Forenede Stater
      • Owensboro, Kentucky, Forenede Stater
    • Louisiana
      • Lafayette, Louisiana, Forenede Stater
      • Lake Charles, Louisiana, Forenede Stater
    • Maine
      • Bangor, Maine, Forenede Stater
    • Maryland
      • Baltimore, Maryland, Forenede Stater
      • Cumberland, Maryland, Forenede Stater
    • Massachusetts
      • Worcester, Massachusetts, Forenede Stater
    • Michigan
      • Detroit, Michigan, Forenede Stater
      • Flint, Michigan, Forenede Stater
      • Lansing, Michigan, Forenede Stater
      • Rochester Hills, Michigan, Forenede Stater
      • Wyoming, Michigan, Forenede Stater
      • Ypsilanti, Michigan, Forenede Stater
    • Missouri
      • Saint Louis, Missouri, Forenede Stater
    • New Jersey
      • Clifton, New Jersey, Forenede Stater
    • New York
      • Mineola, New York, Forenede Stater
      • Stony Brook, New York, Forenede Stater
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater
    • North Dakota
      • Fargo, North Dakota, Forenede Stater
    • Ohio
      • Cincinnati, Ohio, Forenede Stater
      • Middletown, Ohio, Forenede Stater
      • Steubenville, Ohio, Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater
    • South Carolina
      • Anderson, South Carolina, Forenede Stater
      • Columbia, South Carolina, Forenede Stater
      • Greenville, South Carolina, Forenede Stater
      • Lancaster, South Carolina, Forenede Stater
      • Mount Pleasant, South Carolina, Forenede Stater
      • Rock Hill, South Carolina, Forenede Stater
    • Texas
      • Corpus Christi, Texas, Forenede Stater
      • Fort Worth, Texas, Forenede Stater
      • Houston, Texas, Forenede Stater
      • Kingwood, Texas, Forenede Stater
      • San Antonio, Texas, Forenede Stater
      • Tomball, Texas, Forenede Stater
    • Vermont
      • Burlington, Vermont, Forenede Stater
    • Virginia
      • Chesapeake, Virginia, Forenede Stater
      • Fredericksburg, Virginia, Forenede Stater
      • Norfolk, Virginia, Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater

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

The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.

Beskrivelse

Inclusion Criteria:

  • Implanted within the last 30 days or candidate for implantation of a BIOTRONIK ICD or CRT-D DF4 compatible system along with the Protego DF4 lead
  • Meets ICD or CRT-D system implant recommendations as defined in guidelines published by relevant professional societies
  • Able to understand the nature of the registry and provide informed consent
  • Available for follow-up visits on a regular basis at the investigational site for the expected 5 years of follow-up
  • Age greater than or equal to 18 years

Exclusion Criteria:

  • Enrolled in any investigational cardiac device trial
  • Planned cardiac surgical procedures or interventional measures within the next 6 months
  • Expected to receive heart transplantation or ventricular assist device within 1 year
  • Life expectancy of less than 1 year
  • Presence of another life-threatening, underlying illness separate from their cardiac disorder
  • Patients reporting pregnancy at the time of enrollment

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Subjects With No Protego DF4 Lead Adverse Event
Tidsramme: Up to 4.5 years
Evaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate.
Up to 4.5 years
Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
Tidsramme: Up to 4.5 years
Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'.
Up to 4.5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Protego DF4 Lead Pacing Threshold Measurement
Tidsramme: Up to 4.5 years
Pacing threshold measurements at pulse width of 0.4 or 0.5 ms for the Protego DF4 leads through 5 years of follow-up.
Up to 4.5 years
Protego DF4 Lead Shock Impedance
Tidsramme: Up to 4.5 years
Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up.
Up to 4.5 years
Percentage of Subjects With no Adverse Events Excluded From Primary Objectives
Tidsramme: Up to 4.5 years
The overall percentage of patients without adverse events that were excluded from the primary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR).
Up to 4.5 years
Protego DF4 Lead Sensing
Tidsramme: Up to 4.5 years
Sensing measurements for the Protego DF4 leads through 5 years of follow-up.
Up to 4.5 years
Protego DF4 Lead Pacing Impedance
Tidsramme: Up to 4.5 years
Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up.
Up to 4.5 years

Samarbejdspartnere og efterforskere

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

Sponsor

Biotronik, Inc.

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. september 2014

Primær færdiggørelse (Faktiske)

17. april 2019

Studieafslutning (Faktiske)

17. april 2019

Datoer for studieregistrering

Først indsendt

11. september 2014

Først indsendt, der opfyldte QC-kriterier

16. september 2014

Først opslået (Skøn)

18. september 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2020

Sidst verificeret

1. juni 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • P980023/S057

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 .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Dominican Republic

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner