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Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

31. januar 2019 opdateret af: Boston Scientific Corporation

Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead

The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term performance of the ACUITY Spiral Left Ventricular Lead.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1308

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, 35294
        • University of Alabama at Birmingham
      • Birmingham, Alabama, Forenede Stater, 35235
        • Birmingham Heart Clinic
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Mesa, Arizona, Forenede Stater, 85206
        • Tri-City Cardiology
      • Scottsdale, Arizona, Forenede Stater, 85258
        • Arizona Arrhythmia Research Center
      • Tucson, Arizona, Forenede Stater, 85712
        • Pima Heart Physicians
    • Arkansas
      • Jonesboro, Arkansas, Forenede Stater, 72401
        • Cardiology Associates of Northeast Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Heart Clinic Arkansas
    • California
      • Bakersfield, California, Forenede Stater, 93309
        • Comprehensive Cardiovascular Medical Group
      • El Cajon, California, Forenede Stater, 92021
        • Belott Cardiology
      • Fullerton, California, Forenede Stater, 92835
        • Fullerton Cardiovascular
      • Los Angeles, California, Forenede Stater, 90033
        • Cardiac Device Rhythm Specialists
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars - Sinai Medical Center
      • Modesto, California, Forenede Stater, 95355
        • Memorial Hospital
      • Northridge, California, Forenede Stater, 91325
        • Cardiac Rhythm Specialists, Inc.
      • Oakland, California, Forenede Stater, 94609
        • Cardiovascular Consultants
      • Orange, California, Forenede Stater, 92868
        • Orange County Heart Institute
      • Rancho Mirage, California, Forenede Stater, 92270
        • Eisenhower Medical Center
      • Riverside, California, Forenede Stater, 92501
        • Truong D Duong Cardiac Electrophysiology
      • Sacramento, California, Forenede Stater, 95819
        • Regional Cardiology Associates
      • Santa Barbara, California, Forenede Stater, 93102
        • Sansum Clinic
    • Florida
      • Atlantis, Florida, Forenede Stater, 33462
        • Bethesda Memorial Hospital
      • Clearwater, Florida, Forenede Stater, 33756
        • Heart and Vascular Institute of Florida
      • Miami, Florida, Forenede Stater, 33137
        • Miami International Cardiology Consultants
      • New Smyrna Beach, Florida, Forenede Stater, 32168
        • Complete Cardiology Care
      • Orlando, Florida, Forenede Stater, 32806
        • Orlando Regional Hospital
      • Tallahassee, Florida, Forenede Stater, 32308
        • Tallahassee Memorial Hospital
      • Trinity, Florida, Forenede Stater, 34655
        • West Coast Arrhythmia Center
    • Georgia
      • Albany, Georgia, Forenede Stater, 31701
        • Phoebe Putney Memorial Hospital
      • Augusta, Georgia, Forenede Stater, 30912
        • Medical College of Georgia Health
      • Gainesville, Georgia, Forenede Stater, 30501
        • Northeast Georgia Heart Center
      • Macon, Georgia, Forenede Stater, 31201
        • Georgia Arrhythmia Consultants
    • Idaho
      • Boise, Idaho, Forenede Stater, 83712
        • St Lukes Idaho Cardiology Assoc.
    • Illinois
      • Elk Grove Village, Illinois, Forenede Stater, 60007
        • Alexian Brothers Medical Center
      • Mokena, Illinois, Forenede Stater, 60448
        • Heart Care Research Foundation
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater, 46804
        • Northern Indiana Research Alliance
      • Hobart, Indiana, Forenede Stater, 46342
        • St. Mary Medical Center - Indiana
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67214
        • Via-Christi Regional Medical Center
    • Kentucky
      • Bowling Green, Kentucky, Forenede Stater, 42101
        • Southern Kentucky Heart Institute
      • Lexington, Kentucky, Forenede Stater, 40504
        • St. Joseph Hospital
      • Lexington, Kentucky, Forenede Stater, 40503
        • Central Baptist Hospital
      • Louisville, Kentucky, Forenede Stater, 40202
        • Commonwealth Cardiology
    • Maryland
      • Randallstown, Maryland, Forenede Stater, 21133
        • Baltimore Heart Association
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Forenede Stater, 02135
        • Steward St. Elizabeth's Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • St. Joseph Mercy Hospital
      • Detroit, Michigan, Forenede Stater, 48201
        • Heart Care
      • Flint, Michigan, Forenede Stater, 48507
        • Cardiology Consultants of East Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49301
        • West Michigan Heart
      • Southfield, Michigan, Forenede Stater, 48075
        • Providence Hospital
    • Minnesota
      • Duluth, Minnesota, Forenede Stater, 55805
        • St. Mary's Duluth Clinic
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65201
        • Missouri Heart Center
      • Kansas City, Missouri, Forenede Stater, 64114
        • Research Medical Center
      • Saint Louis, Missouri, Forenede Stater, 63128
        • Metro Heart Group South County
      • Springfield, Missouri, Forenede Stater, 65807
        • Cox Health
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68526
        • Nebraska Heart Institute
    • New Jersey
      • West Orange, New Jersey, Forenede Stater, 07052
        • New Jersey Cardiology Associates
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Capital Cardiology Associates
      • Garden City, New York, Forenede Stater, 11530
        • Island Cardiac Specialists
      • New York, New York, Forenede Stater, 10032
        • Columbia University Medical Center
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Mid-Carolina Cardiology
      • Pinehurst, North Carolina, Forenede Stater, 28374
        • Pinehurst Cardiology Consultants
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Christ Hospital - Cincinnati
      • Columbus, Ohio, Forenede Stater, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Forenede Stater, 43210
        • Ohio State University Medical Center
      • Steubenville, Ohio, Forenede Stater, 43952
        • Regional Cardiovascular Medical Center
      • Zanesville, Ohio, Forenede Stater, 43701
        • Genesis Healthcare System
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74101
        • Hillcrest Medical Center
    • Pennsylvania
      • Abington, Pennsylvania, Forenede Stater, 19001
        • Abington Memorial Hospital
      • Harrisburg, Pennsylvania, Forenede Stater, 17112
        • Associated Cardiologists
      • Philadelphia, Pennsylvania, Forenede Stater, 19141
        • Albert Einstein Medical Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19102
        • Drexel University College of Medicine
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • Lankenau Hospital
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02904
        • Cardiovascular Associates of Rhode Island
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29204
        • Columbia Cardiology
      • Florence, South Carolina, Forenede Stater, 29505
        • PeeDee Cardiology Associates
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57701
        • Heart Doctors
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 37501
        • Memphis Heart Clinic
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Amarillo Heart Group
      • Austin, Texas, Forenede Stater, 78756
        • Heart Hospital of Austin
      • Austin, Texas, Forenede Stater, 78705
        • Texas Cardiac Arrhythmia Research
      • El Paso, Texas, Forenede Stater, 79902
        • Cardiology Care Consultants
      • Houston, Texas, Forenede Stater, 77030
        • Hall Garcia Cardiology
      • Houston, Texas, Forenede Stater, 77030
        • Houston Electrophysiology Associates
      • Houston, Texas, Forenede Stater, 77030
        • Willowbrook Cardiovascular Associates
      • The Woodlands, Texas, Forenede Stater, 77384
        • EP Heart
      • Tyler, Texas, Forenede Stater, 75701
        • Tyler Cardiovascular Consultants
    • Utah
      • Murray, Utah, Forenede Stater, 84107
        • Intermountain Medical Center
      • Saint George, Utah, Forenede Stater, 84790
        • Dixie Regional Medical Center
    • Virginia
      • Falls Church, Virginia, Forenede Stater, 22042
        • Virginia Heart
      • Mechanicsville, Virginia, Forenede Stater, 23116
        • Richmond Cardiology Associates
    • Washington
      • Bellevue, Washington, Forenede Stater, 98004
        • Overlake Medical Center
      • Bellingham, Washington, Forenede Stater, 98225
        • St. Joseph Hospital
      • Seattle, Washington, Forenede Stater, 98133
        • Swedish Medical Center
      • Spokane, Washington, Forenede Stater, 99204
        • Heart Clinics Northwest
    • Wisconsin
      • Wauwatosa, Wisconsin, Forenede Stater, 53226
        • Wheaton Franciscan Healthcare

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The population will be a broad base representative of those recieving the ACUITY Spiral lead.

Beskrivelse

Inclusion Criteria:

  • Has been or will be implanted with the ACUITY Spiral Lead within 29 days
  • Plans to remain in the long-term care of his/her enrolling physician
  • Is willing and capable (or appropriate legal representative) of authorizing access to and use of health information as required by an institution's institutional review board (IRB)
  • Is willing and capable (or appropriate legal representative) of providing authorization for participation in the registry

Exclusion Criteria:

  • Is unable or unwilling to comply with the protocol requirements

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Implants
Patients successfully implanted with the ACUITY Spiral Lead
Enhed: ACUITY Spiral Left Ventricular Lead
The implant of the ACUITY Spiral Lead

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Chronic Left Ventricular Lead-related Complication Free Rate
Tidsramme: Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).
Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).

Samarbejdspartnere og efterforskere

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

Sponsor

Boston Scientific Corporation

Efterforskere

  • Studieleder: Olaf Hedrich, MD, Boston Scientific Corporation

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)

4. august 2009

Primær færdiggørelse (Faktiske)

28. februar 2018

Studieafslutning (Faktiske)

28. februar 2018

Datoer for studieregistrering

Først indsendt

4. august 2009

Først indsendt, der opfyldte QC-kriterier

7. august 2009

Først opslået (Skøn)

10. august 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. januar 2019

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LSR of ACUITY Spiral

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

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 ACUITY Spiral Left Ventricular Lead

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Uganda

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner