Longitudinal Surveillance Registry (LSR) of ACUITY Spiral
31. januar 2019 oppdatert av: 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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
1308
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35294
- University of Alabama at Birmingham
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Birmingham, Alabama, Forente stater, 35235
- Birmingham Heart Clinic
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Alaska
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Anchorage, Alaska, Forente stater, 99508
- Providence Alaska Medical Center
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Arizona
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Mesa, Arizona, Forente stater, 85206
- Tri-City Cardiology
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Scottsdale, Arizona, Forente stater, 85258
- Arizona Arrhythmia Research Center
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Tucson, Arizona, Forente stater, 85712
- Pima Heart Physicians
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Arkansas
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Jonesboro, Arkansas, Forente stater, 72401
- Cardiology Associates of Northeast Arkansas
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Little Rock, Arkansas, Forente stater, 72205
- Heart Clinic Arkansas
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California
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Bakersfield, California, Forente stater, 93309
- Comprehensive Cardiovascular Medical Group
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El Cajon, California, Forente stater, 92021
- Belott Cardiology
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Fullerton, California, Forente stater, 92835
- Fullerton Cardiovascular
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Los Angeles, California, Forente stater, 90033
- Cardiac Device Rhythm Specialists
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Los Angeles, California, Forente stater, 90048
- Cedars - Sinai Medical Center
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Modesto, California, Forente stater, 95355
- Memorial Hospital
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Northridge, California, Forente stater, 91325
- Cardiac Rhythm Specialists, Inc.
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Oakland, California, Forente stater, 94609
- Cardiovascular Consultants
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Orange, California, Forente stater, 92868
- Orange County Heart Institute
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Rancho Mirage, California, Forente stater, 92270
- Eisenhower Medical Center
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Riverside, California, Forente stater, 92501
- Truong D Duong Cardiac Electrophysiology
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Sacramento, California, Forente stater, 95819
- Regional Cardiology Associates
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Santa Barbara, California, Forente stater, 93102
- Sansum Clinic
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Florida
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Atlantis, Florida, Forente stater, 33462
- Bethesda Memorial Hospital
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Clearwater, Florida, Forente stater, 33756
- Heart and Vascular Institute of Florida
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Miami, Florida, Forente stater, 33137
- Miami International Cardiology Consultants
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New Smyrna Beach, Florida, Forente stater, 32168
- Complete Cardiology Care
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Orlando, Florida, Forente stater, 32806
- Orlando Regional Hospital
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Tallahassee, Florida, Forente stater, 32308
- Tallahassee Memorial Hospital
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Trinity, Florida, Forente stater, 34655
- West Coast Arrhythmia Center
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Georgia
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Albany, Georgia, Forente stater, 31701
- Phoebe Putney Memorial Hospital
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Augusta, Georgia, Forente stater, 30912
- Medical College of Georgia Health
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Gainesville, Georgia, Forente stater, 30501
- Northeast Georgia Heart Center
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Macon, Georgia, Forente stater, 31201
- Georgia Arrhythmia Consultants
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Idaho
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Boise, Idaho, Forente stater, 83712
- St Lukes Idaho Cardiology Assoc.
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Illinois
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Elk Grove Village, Illinois, Forente stater, 60007
- Alexian Brothers Medical Center
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Mokena, Illinois, Forente stater, 60448
- Heart Care Research Foundation
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Indiana
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Fort Wayne, Indiana, Forente stater, 46804
- Northern Indiana Research Alliance
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Hobart, Indiana, Forente stater, 46342
- St. Mary Medical Center - Indiana
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Kansas
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Wichita, Kansas, Forente stater, 67214
- Via-Christi Regional Medical Center
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Kentucky
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Bowling Green, Kentucky, Forente stater, 42101
- Southern Kentucky Heart Institute
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Lexington, Kentucky, Forente stater, 40504
- St. Joseph Hospital
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Lexington, Kentucky, Forente stater, 40503
- Central Baptist Hospital
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Louisville, Kentucky, Forente stater, 40202
- Commonwealth Cardiology
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Maryland
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Randallstown, Maryland, Forente stater, 21133
- Baltimore Heart Association
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Forente stater, 02135
- Steward St. Elizabeth's Medical Center
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Michigan
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Ann Arbor, Michigan, Forente stater, 48106
- St. Joseph Mercy Hospital
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Detroit, Michigan, Forente stater, 48201
- Heart Care
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Flint, Michigan, Forente stater, 48507
- Cardiology Consultants of East Michigan
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Grand Rapids, Michigan, Forente stater, 49301
- West Michigan Heart
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Southfield, Michigan, Forente stater, 48075
- Providence Hospital
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Minnesota
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Duluth, Minnesota, Forente stater, 55805
- St. Mary's Duluth Clinic
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Missouri
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Columbia, Missouri, Forente stater, 65201
- Missouri Heart Center
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Kansas City, Missouri, Forente stater, 64114
- Research Medical Center
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Saint Louis, Missouri, Forente stater, 63128
- Metro Heart Group South County
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Springfield, Missouri, Forente stater, 65807
- Cox Health
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Nebraska
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Lincoln, Nebraska, Forente stater, 68526
- Nebraska Heart Institute
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New Jersey
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West Orange, New Jersey, Forente stater, 07052
- New Jersey Cardiology Associates
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New York
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Albany, New York, Forente stater, 12208
- Capital Cardiology Associates
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Garden City, New York, Forente stater, 11530
- Island Cardiac Specialists
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New York, New York, Forente stater, 10032
- Columbia University Medical Center
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North Carolina
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Charlotte, North Carolina, Forente stater, 28204
- Mid-Carolina Cardiology
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Pinehurst, North Carolina, Forente stater, 28374
- Pinehurst Cardiology Consultants
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
- Christ Hospital - Cincinnati
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Columbus, Ohio, Forente stater, 43214
- Riverside Methodist Hospital
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Columbus, Ohio, Forente stater, 43210
- Ohio State University Medical Center
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Steubenville, Ohio, Forente stater, 43952
- Regional Cardiovascular Medical Center
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Zanesville, Ohio, Forente stater, 43701
- Genesis HealthCare System
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Oklahoma
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Tulsa, Oklahoma, Forente stater, 74101
- Hillcrest Medical Center
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Pennsylvania
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Abington, Pennsylvania, Forente stater, 19001
- Abington Memorial Hospital
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Harrisburg, Pennsylvania, Forente stater, 17112
- Associated Cardiologists
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Philadelphia, Pennsylvania, Forente stater, 19141
- Albert Einstein Medical Center
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Philadelphia, Pennsylvania, Forente stater, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19102
- Drexel University College of Medicine
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Wynnewood, Pennsylvania, Forente stater, 19096
- Lankenau Hospital
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Rhode Island
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Providence, Rhode Island, Forente stater, 02904
- Cardiovascular Associates of Rhode Island
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South Carolina
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Columbia, South Carolina, Forente stater, 29204
- Columbia Cardiology
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Florence, South Carolina, Forente stater, 29505
- PeeDee Cardiology Associates
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South Dakota
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Rapid City, South Dakota, Forente stater, 57701
- Heart Doctors
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Tennessee
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Memphis, Tennessee, Forente stater, 37501
- Memphis Heart Clinic
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Texas
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Amarillo, Texas, Forente stater, 79106
- Amarillo Heart Group
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Austin, Texas, Forente stater, 78756
- Heart Hospital of Austin
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Austin, Texas, Forente stater, 78705
- Texas Cardiac Arrhythmia Research
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El Paso, Texas, Forente stater, 79902
- Cardiology Care Consultants
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Houston, Texas, Forente stater, 77030
- Hall Garcia Cardiology
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Houston, Texas, Forente stater, 77030
- Houston Electrophysiology Associates
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Houston, Texas, Forente stater, 77030
- Willowbrook Cardiovascular Associates
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The Woodlands, Texas, Forente stater, 77384
- EP Heart
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Tyler, Texas, Forente stater, 75701
- Tyler Cardiovascular Consultants
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Utah
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Murray, Utah, Forente stater, 84107
- Intermountain Medical Center
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Saint George, Utah, Forente stater, 84790
- Dixie Regional Medical Center
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Virginia
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Falls Church, Virginia, Forente stater, 22042
- Virginia Heart
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Mechanicsville, Virginia, Forente stater, 23116
- Richmond Cardiology Associates
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Washington
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Bellevue, Washington, Forente stater, 98004
- Overlake Medical Center
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Bellingham, Washington, Forente stater, 98225
- St. Joseph Hospital
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Seattle, Washington, Forente stater, 98133
- Swedish Medical Center
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Spokane, Washington, Forente stater, 99204
- Heart Clinics Northwest
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Wisconsin
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Wauwatosa, Wisconsin, Forente stater, 53226
- Wheaton Franciscan Healthcare
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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
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Implants
Patients successfully implanted with the ACUITY Spiral Lead
|
The implant of the ACUITY Spiral Lead
|
Hva måler studien?
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).
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Olaf Hedrich, MD, Boston Scientific Corporation
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)
4. august 2009
Primær fullføring (Faktiske)
28. februar 2018
Studiet fullført (Faktiske)
28. februar 2018
Datoer for studieregistrering
Først innsendt
4. august 2009
Først innsendt som oppfylte QC-kriteriene
7. august 2009
Først lagt ut (Anslag)
10. august 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. mai 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. januar 2019
Sist bekreftet
1. juli 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LSR of ACUITY Spiral
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
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. .