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OptiVol® Care Pathway

30. april 2013 opdateret af: Medtronic Cardiac Rhythm and Heart Failure
Medtronic, Inc. is sponsoring the OptiVol® Care Pathway Study, a prospective, randomized, multi-center, post-market clinical trial in the United States. The purpose of this clinical trial is to compare monthly versus quarterly review of Cardiac Compass® Trends with OptiVol for initiation of clinical action. It is hypothesized that monthly review of Cardiac Compass Trends with OptiVol will shorten time to clinical action as compared to quarterly review.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1682

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater
      • Mobile, Alabama, Forenede Stater
    • Alaska
      • Anchorage, Alaska, Forenede Stater
    • Arizona
      • Mesa, Arizona, Forenede Stater
    • Arkansas
      • Ft. Smith, Arkansas, Forenede Stater
      • Little Rock, Arkansas, Forenede Stater
    • California
      • Alhambra, California, Forenede Stater
      • Berkeley, California, Forenede Stater
      • Burbank, California, Forenede Stater
      • Chula Vista, California, Forenede Stater
      • La Jolla, California, Forenede Stater
      • Larkspur, California, Forenede Stater
      • Pomona, California, Forenede Stater, 91767
      • Rancho Mirage, California, Forenede Stater
      • Riverside, California, Forenede Stater
      • San Francisco, California, Forenede Stater, 94115
      • Torrance, California, Forenede Stater
    • Colorado
      • Boulder, Colorado, Forenede Stater
      • Colorado Springs, Colorado, Forenede Stater
    • Florida
      • Brandenton, Florida, Forenede Stater
      • Clearwater, Florida, Forenede Stater
      • Daytona Beach, Florida, Forenede Stater
      • Ft. Lauderdale, Florida, Forenede Stater
      • Gainesville, Florida, Forenede Stater
      • Inverness, Florida, Forenede Stater
      • Jacksonville, Florida, Forenede Stater
      • Jupiter, Florida, Forenede Stater
      • Miami, Florida, Forenede Stater
      • Orlando, Florida, Forenede Stater
      • Trinity, Florida, Forenede Stater
    • Georgia
      • Augusta, Georgia, Forenede Stater
      • Columbus, Georgia, Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater
      • Kankakee, Illinois, Forenede Stater
      • Oak Lawn, Illinois, Forenede Stater
      • Rockford, Illinois, Forenede Stater
    • Indiana
      • Bloomington, Indiana, Forenede Stater
      • Muncie, Indiana, Forenede Stater
      • Munster, Indiana, Forenede Stater
      • Terre Haute, Indiana, Forenede Stater
    • Iowa
      • Davenport, Iowa, Forenede Stater
      • Des Moines, Iowa, Forenede Stater
    • Kentucky
      • Ashland, Kentucky, Forenede Stater
      • Lexington, Kentucky, Forenede Stater
      • Louisville, Kentucky, Forenede Stater
    • Louisiana
      • Shreveport, Louisiana, Forenede Stater
    • Maine
      • Bangor, Maine, Forenede Stater
    • Maryland
      • Glen Burnie, Maryland, Forenede Stater
      • Rockville, Maryland, Forenede Stater
      • Salisbury, Maryland, Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48236
      • Grand Blanc, Michigan, Forenede Stater
      • Grand Rapids, Michigan, Forenede Stater
      • Petosky, Michigan, Forenede Stater
      • Sterling Heights, Michigan, Forenede Stater
    • Minnesota
      • Coon Rapids, Minnesota, Forenede Stater
      • Minneapolis, Minnesota, Forenede Stater
      • St. Cloud, Minnesota, Forenede Stater
    • Missouri
      • Columbia, Missouri, Forenede Stater
      • Kansas City, Missouri, Forenede Stater
      • Springfield, Missouri, Forenede Stater
      • St. Joseph, Missouri, Forenede Stater
      • St. Louis, Missouri, Forenede Stater
    • Nebraska
      • Omaha, Nebraska, Forenede Stater
    • Nevada
      • Reno, Nevada, Forenede Stater
    • New Jersey
      • Bridgewater, New Jersey, Forenede Stater
      • Galloway, New Jersey, Forenede Stater
      • Newark, New Jersey, Forenede Stater, 07105
      • Ocean, New Jersey, Forenede Stater, 07712
      • Voorhees, New Jersey, Forenede Stater
    • New York
      • Buffalo, New York, Forenede Stater
      • Fayetteville, New York, Forenede Stater
      • Garden City, New York, Forenede Stater, 11530
    • North Carolina
      • Durham, North Carolina, Forenede Stater
      • Gastonia, North Carolina, Forenede Stater
      • Greensboro, North Carolina, Forenede Stater
      • Wilmington, North Carolina, Forenede Stater
    • North Dakota
      • Minot, North Dakota, Forenede Stater
    • Ohio
      • Akron, Ohio, Forenede Stater
      • Cleveland, Ohio, Forenede Stater
      • Kettering, Ohio, Forenede Stater
      • Poland, Ohio, Forenede Stater, 44514
      • Steubenville, Ohio, Forenede Stater
      • Toledo, Ohio, Forenede Stater
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
    • Oregon
      • Bend, Oregon, Forenede Stater
    • Pennsylvania
      • Doylestown, Pennsylvania, Forenede Stater
      • Lancaster, Pennsylvania, Forenede Stater
      • Philadelphia, Pennsylvania, Forenede Stater
      • Pittsburgh, Pennsylvania, Forenede Stater
      • Wynnewood, Pennsylvania, Forenede Stater
    • South Carolina
      • Columbia, South Carolina, Forenede Stater
      • Greenwood, South Carolina, Forenede Stater
      • Spartanburg, South Carolina, Forenede Stater
      • West Columbia, South Carolina, Forenede Stater
    • Tennessee
      • Germantown, Tennessee, Forenede Stater
      • Johnson City, Tennessee, Forenede Stater
      • Memphis, Tennessee, Forenede Stater, 38120
      • Nashville, Tennessee, Forenede Stater
    • Texas
      • Austin, Texas, Forenede Stater
      • Corpus Christi, Texas, Forenede Stater
      • McAllen, Texas, Forenede Stater
      • San Antonio, Texas, Forenede Stater
      • Tyler, Texas, Forenede Stater
    • Virginia
      • Lynchburg, Virginia, Forenede Stater
    • Washington
      • Spokane, Washington, Forenede Stater
    • Wisconsin
      • Madison, Wisconsin, 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

Beskrivelse

Inclusion Criteria:

  • Subject (or subject's legally authorized representative) is willing and able to sign and date written consent form and Authorization for Access to and Use of Health Information
  • Subject is at least 18 years of age
  • Subject is willing and able to comply with Clinical Investigation Plan
  • Subject is willing and able to transmit data using Medtronic CareLink® Network
  • Subject has market released right atrial (RA) (if applicable), right ventricular (RV), and left ventricular (LV) (if applicable) leads and one of the following generators implanted: Concerto® CRT-D - Model C154DWK, Virtuoso® DR ICD - Model D154AWG, Virtuoso® VR ICD - Model D154VWC, Consulta™ CRT-D - Model D224TRK, Secura™ DR ICD - Model D224DRG, Secura™ VR ICD - Model D224VRC, or any future market released Medtronic generator with wireless telemetry, Cardiac Compass with OptiVol Fluid Status Monitoring, and that is supported by the Medtronic CareLink Network

Exclusion Criteria:

  • Subject is enrolled in a concurrent study with the exception of a study approved by the Medtronic Clinical Trial Leader prior to enrollment
  • Subject has life expectancy of less than 1 year

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Monthly Review Arm
Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
Andet: Monthly Review Arm
Monthly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.
Aktiv komparator: Quarterly Review Arm
Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
Andet: Quarterly Review Arm
Quarterly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Compare the Time to Initiation of Clinical Action Prompted by an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol
Tidsramme: 1 year
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm
Tidsramme: 1 year

There are 3 summary scale scores for the Self-Care of Heart Failure Index (SCHFI) form: self-care maintenance score (Section A), management score (Section B), and confidence score (Section C). Each scale score is standardized to a 0 to 100 range, with 0 indicating the worst and 100 indicating the best performance for each scale score.

Here, changes in each scale score between 6 month follow-up and baseline and between 12 month follow-up and baseline are the secondary outcome measures. Specifically, change at 6 (or 12) month follow-up is calculated as a scale score at 6 (or 12) month follow-up subtracts that at baseline. These changes range from -100 to 100 with 0 indicating no change at all, -100 indicating maximum decrease and 100 indicating maximum increase that is possible from baseline for a self-care scale score.
1 year
Identify Patient Groups Who Are More Likely to Have Clinical Actions Triggered by Monthly Rather Than Quarterly Reviews
Tidsramme: 1 year
The binary outcome of having clinical actions taken (Yes/No) is recorded within one month interval for the monthly review group, and within three months interval for the quarterly review group. To make the endpoints of both groups comparable, data from monthly review group are converted as they were collected quarterly. For example, the month 1, 2 and 3 visits of monthly review group are combined as one visit. If there is at least one action taken in any of these three monthly visits, the action taken variable for the combined visit will be recorded as 'yes'. Unscheduled visits in both groups are lumped to the next quarterly time point.
1 year
Compare the Time to Initiation of Clinical Action With or Without an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol
Tidsramme: 1 year
1 year

Samarbejdspartnere og efterforskere

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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Efterforskere

  • Ledende efterforsker: Wilson Tang, MD, Department of Cardiovascular Medicine, Cleveland Clinic

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

1. marts 2009

Primær færdiggørelse (Faktiske)

1. marts 2011

Studieafslutning (Faktiske)

1. maj 2011

Datoer for studieregistrering

Først indsendt

13. februar 2009

Først indsendt, der opfyldte QC-kriterier

17. februar 2009

Først opslået (Skøn)

19. februar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. maj 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2013

Sidst verificeret

1. april 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OptiVol® Care Pathway

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 Monthly Review Arm

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Poland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner