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OptiVol® Care Pathway

30. april 2013 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1682

Fase

  • Fase 4

Kontakter og plasseringer

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

Studiesteder

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

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

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Monthly Review Arm
Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
Annen: 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
Annen: Quarterly Review Arm
Quarterly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.

Hva måler studien?

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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Etterforskere

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

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

1. mars 2009

Primær fullføring (Faktiske)

1. mars 2011

Studiet fullført (Faktiske)

1. mai 2011

Datoer for studieregistrering

Først innsendt

13. februar 2009

Først innsendt som oppfylte QC-kriteriene

17. februar 2009

Først lagt ut (Anslag)

19. februar 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

3. mai 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. april 2013

Sist bekreftet

1. april 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • OptiVol® Care Pathway

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. .

Kliniske studier på Hjertefeil

Kliniske studier på Monthly Review Arm

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in France

Forhold

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Legemiddelintervensjoner

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