- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01596595
Longitudinel overvågningsundersøgelse af 4-SITE Lead/Header-systemet (LSS of 4-SITE)
Studieoversigt
Status
Detaljeret beskrivelse
Formålet med LSS of 4-SITE-undersøgelsen er prospektivt at bestemme den kroniske komplikationsfri rate af 4-SITE Lead/Header-systemet for at verificere dets kliniske ydeevne, langsigtede pålidelighed og funktionelle integritet. LSS of 4-SITE Study er en ikke-randomiseret, multicenter, global klinisk undersøgelse af forsøgspersoner implanteret med 4-SITE Lead/Header System. Undersøgelsen er designet til at indsamle oplysninger om produktets ydeevne, alle rapporterbare bivirkninger og tilbagetrækningsdata.
Det primære formål med denne undersøgelse er at evaluere, dokumentere og rapportere om den passende kliniske ydeevne, den langsigtede pålidelighed og den funktionelle integritet af 4-SITE Lead/Header System. Dette 4-SITE lednings-/hovedsystem består af en 4-SITE ENDOTAK® RELIANCE defibrilleringsledning forbundet til en 4-SITE Header (som er den eneste PG-komponent, der er undersøgt) i en enkelt- eller dobbeltkammer (VR og DR) implanterbar cardioverter-defibrillator (ICD) eller en hjerteresynkroniseringsterapi ICD (CRT-D) BSC-pulsgenerator. Derudover vil systemrelateret diagnostisk information og implantatdata blive indsamlet under udførelsen af denne undersøgelse.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Western Australia
-
Perth, Western Australia, Australien, 6000
- Mount Hospital
-
-
-
-
Alberta
-
Calgary, Alberta, Canada
- Foothills Medical Centre
-
Edmonton, Alberta, Canada
- University of Alberta Hospital
-
-
British Columbia
-
New Westminster, British Columbia, Canada, V3L 3W7
- Royal Columbian Hospital
-
-
Ontario
-
Hamilton, Ontario, Canada, L8L 2X2
- Hamilton General Hospital
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1H5N4
- Fleurimont Hospital
-
Ste Foy, Quebec, Canada, G1V 4G5
- Institut Universitaire De Cardiologie Et De Pneumologie De Québec
-
-
-
-
Alaska
-
Anchorage, Alaska, Forenede Stater, 99508
- Providence Alaska Medical Center
-
-
Arizona
-
Glendale, Arizona, Forenede Stater, 85032
- Cardiovascular Consultants, Ltd
-
Mesa, Arizona, Forenede Stater, 85206
- CardioVascular Associates of Mesa
-
Phoenix, Arizona, Forenede Stater, 85006
- Phoenix Cardiovascular Research Group
-
-
Arkansas
-
Little Rock, Arkansas, Forenede Stater, 72205
- Heart Clinic Arkansas
-
-
California
-
Burbank, California, Forenede Stater, 91505
- Providence St. Joseph Medical Center
-
Escondido, California, Forenede Stater, 92025
- Palomar Medical Center
-
Fountain Valley, California, Forenede Stater, 92708
- California Heart Associates
-
Fountain Valley, California, Forenede Stater, 92708
- Luc Sinh Nguyen, MD, FACC, Inc.
-
Los Angeles, California, Forenede Stater, 90033
- Cardiac Device Rhythm Specialists
-
Los Angeles, California, Forenede Stater, 90024
- Providence Holy Cross Medical Center
-
Los Angeles, California, Forenede Stater, 93309
- Comprehensive Cardiovascular Medical Group
-
Palm Springs, California, Forenede Stater, 62262
- Desert Regional Medical Center
-
Riverside, California, Forenede Stater, 92503
- Truong D. Duong, MD. A Medical Corporation
-
San Diego, California, Forenede Stater, 92103
- San Diego Arrhythmia Associates
-
San Jose, California, Forenede Stater, 95124
- Good Samaritan Hospital - San Jose
-
Santa Barbara, California, Forenede Stater, 93102
- Santa Barbara Cottage Hospital
-
Torrance, California, Forenede Stater, 90503
- Little Company of Mary Hospital
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80045
- University of Colorado Hospital
-
Denver, Colorado, Forenede Stater, 80120
- South Denver Cardiology Associates, PC
-
-
Connecticut
-
Danbury, Connecticut, Forenede Stater, 06810
- Danbury Hospital
-
New Haven, Connecticut, Forenede Stater, 06520
- Yale University School of Medicine
-
-
Florida
-
Bradenton, Florida, Forenede Stater, 34205
- Bradenton Cardiology
-
Clearwater, Florida, Forenede Stater, 33756
- Clearwater Cardiovascular Consultants
-
Fort Lauderdale, Florida, Forenede Stater, 33316
- Broward General Medical Center
-
Gainesville, Florida, Forenede Stater, 32605
- North Florida Regional Medical Center
-
Jacksonville, Florida, Forenede Stater, 32216
- First Coast Cardiovascular
-
Jacksonville, Florida, Forenede Stater, 32250
- Baptist Medical Center
-
Kissimmee, Florida, Forenede Stater, 34741
- Osceola Regional Medical Center
-
Miami, Florida, Forenede Stater, 33173
- Cardiovascular Research Center of South Florida
-
Port Charlotte, Florida, Forenede Stater, 33952
- Charlotte Heart & Vascular
-
Rockledge, Florida, Forenede Stater, 32955
- Brevard Cardiovascular Research Associates, Inc.
-
Tallahassee, Florida, Forenede Stater, 32308
- Tallahassee Memorial Hospital
-
Tampa, Florida, Forenede Stater, 33606
- Tampa General Hospital
-
-
Georgia
-
Albany, Georgia, Forenede Stater, 31701
- Phoebe Putney Memorial Hospital
-
Gainesville, Georgia, Forenede Stater, 30501
- Northeast Georgia Heart Center
-
Lawrenceville, Georgia, Forenede Stater, 30046
- Gwinnett Hospital System Inc.
-
Macon, Georgia, Forenede Stater, 31201
- Georgia Arrhythmia Consultants
-
Stockbridge, Georgia, Forenede Stater, 30281
- Atlanta Heart Associates
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60637
- University of Chicago Hospital
-
Hinsdale, Illinois, Forenede Stater, 60521
- Illinois Heart and Vascular at Adventist Hinsdale Hospital
-
Joliet, Illinois, Forenede Stater, 60435
- Heartland Cardiovascular Center
-
Urbana, Illinois, Forenede Stater, 61801
- Carle Foundation Hospital
-
-
Indiana
-
Bloomington, Indiana, Forenede Stater, 47403
- Bloomington Hospital
-
Fort Wayne, Indiana, Forenede Stater, 46805
- Parkview Memorial Hospital
-
-
Iowa
-
Des Moines, Iowa, Forenede Stater, 50314
- Mercy Hospital Medical Center
-
Des Moines, Iowa, Forenede Stater, 50314
- The Iowa Clinic, PC
-
-
Kansas
-
Kansas City, Kansas, Forenede Stater, 64114
- Kansas City Heart Foundation
-
Wichita, Kansas, Forenede Stater, 67214
- Via-Christi Regional Medical Center
-
-
Louisiana
-
New Orleans, Louisiana, Forenede Stater, 70121
- Ochsner Clinic Foundation
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21201
- University of Maryland Medical System
-
Baltimore, Maryland, Forenede Stater, 21237
- MedStar Health Research Institute
-
-
Massachusetts
-
Worcester, Massachusetts, Forenede Stater, 01655
- University of Massachusetts Memorial Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48106
- St. Joseph Mercy Hospital
-
Saginaw, Michigan, Forenede Stater, 48602
- Covenant Medical Center
-
Traverse City, Michigan, Forenede Stater, 49684
- Munson Medical Center
-
-
Minnesota
-
Saint Cloud, Minnesota, Forenede Stater, 56303
- CentraCare Heart and Vascular Center
-
-
Mississippi
-
Jackson, Mississippi, Forenede Stater, 39216
- University of Mississippi Medical Center
-
Tupelo, Mississippi, Forenede Stater, 38801
- North Mississippi Medical Center
-
-
Missouri
-
Saint Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
-
Saint Louis, Missouri, Forenede Stater, 63104
- St. Louis University Hospital
-
Springfield, Missouri, Forenede Stater, 65807
- Cox Health
-
-
Montana
-
Billings, Montana, Forenede Stater, 59107
- Billings Clinic
-
Missoula, Montana, Forenede Stater, 59802
- St. Patrick Hospital
-
-
Nebraska
-
Lincoln, Nebraska, Forenede Stater, 68526
- Nebraska Heart Institute
-
-
New Jersey
-
Browns Mills, New Jersey, Forenede Stater, 08015
- Deborah Heart and Lung Center
-
Englewood, New Jersey, Forenede Stater, 07631
- Englewood Hospital and Medical Center
-
Sewell, New Jersey, Forenede Stater, 08080
- Cardiovascular Associates of the Delaware Valley
-
-
New York
-
Manhasset, New York, Forenede Stater, 11030
- North Shore University Hospital
-
Rochester, New York, Forenede Stater, 14621
- Rochester General Hospital
-
Stony Brook, New York, Forenede Stater, 24421
- SUNY-Stony Brook School of Medicine
-
Williamsville, New York, Forenede Stater, 14221
- Cardiology Group of West New York
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45267
- Universtity of Cincinnati
-
Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals of Cleveland
-
Kettering, Ohio, Forenede Stater, 45429
- Kettering Medical Center
-
Toledo, Ohio, Forenede Stater, 43615
- The Toledo Hospital
-
Zanesville, Ohio, Forenede Stater, 43701
- Genesis Healthcare System
-
-
Oregon
-
Salem, Oregon, Forenede Stater, 97302
- Salem Hospital
-
-
Pennsylvania
-
Newton, Pennsylvania, Forenede Stater, 18940
- The Arrhythmia Institute
-
Philadelphia, Pennsylvania, Forenede Stater, 19102
- Drexel University College of Medicine
-
Yardley, Pennsylvania, Forenede Stater, 19067
- Cardiology Consultants of Philadelphia
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02904
- Southcoast Physicians Group
-
-
South Carolina
-
Columbia, South Carolina, Forenede Stater, 29204
- Sisters of Charity Providence Hospital
-
Florence, South Carolina, Forenede Stater, 29506
- PeeDee Cardiology Associates PA
-
Greenwood, South Carolina, Forenede Stater, 29646
- Piedmont Medical Center
-
Lexington, South Carolina, Forenede Stater, 29072
- Lexington Medical Center
-
Spartanburg, South Carolina, Forenede Stater, 29303
- Spartanburg Regional Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, Forenede Stater, 57701
- Rapid City Regional Hospit
-
-
Tennessee
-
Nashville, Tennessee, Forenede Stater, 37205
- Saint Thomas Health
-
Rogersville, Tennessee, Forenede Stater, 37857
- Wellmont Holston Valley Medical Center
-
-
Texas
-
Beaumont, Texas, Forenede Stater, 77702
- Southeast Texas Clinical Research Center
-
Houston, Texas, Forenede Stater, 77024
- Houston Arrhythmia Associates
-
San Antonio, Texas, Forenede Stater, 78217
- Arrhythmia Associates of South Texas
-
Tyler, Texas, Forenede Stater, 75701
- Trinity Mother Frances Health System
-
-
Utah
-
Murray, Utah, Forenede Stater, 84107
- Intermountain Medical Center
-
Salt Lake City, Utah, Forenede Stater, 84132
- University of Utah Hospital and Clinics
-
-
Virginia
-
Norfolk, Virginia, Forenede Stater, 23507
- Sentara Norfolk General Hospital
-
Richmond, Virginia, Forenede Stater, 23219
- Virginia Commonwealth University Health System
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98101
- Virginia Mason Medical Center
-
-
West Virginia
-
Charleston, West Virginia, Forenede Stater, 25304
- Charleston Area Medical Center
-
Morgantown, West Virginia, Forenede Stater, 26505
- Monongalia General Hospital
-
-
Wisconsin
-
Green Bay, Wisconsin, Forenede Stater, 54305
- Bellin Health
-
Madison, Wisconsin, Forenede Stater, 53713
- Meriter Hospital, Inc.
-
-
Wyoming
-
Cheyenne, Wyoming, Forenede Stater, 82001
- Cheyenne Regional Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- VOKSEN
- OLDER_ADULT
- BARN
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:
- medicinsk indiceret til ICD/CRT-D
- modtaget/planlægger at modtage studieleder
- villig til langvarig opfølgning
Ekskluderingskriterier:
- uvillig til at overholde protokollen
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
Medicinsk indiceret til ICD eller CRT-D
Medicinsk indiceret til ICD- eller CRT-D-implantation i henhold til retningslinjer
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Procentdel af deltagere, der ikke oplever en system- eller procedurerelateret komplikation gennem 5 år
Tidsramme: 5 år
|
4-SITE Lead/Header System vil blive evalueret baseret på "kronisk 4-SITE Lead/Header System-relaterede komplikationsfri rate" for den fem (5) års opfølgningsperiode efter indeksimplantationen.
Den primære endepunktsanalyse vil omfatte bekræftede kroniske 4-SITE Lead/Header System-relaterede komplikationer, der resulterer i forsøgspersonen permanent tab af terapi, invasiv intervention, skade eller død.
|
5 år
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Stephen Kutalek, MD, Drexel University, USA
Datoer for undersøgelser
Studer store datoer
Studiestart (FAKTISKE)
Primær færdiggørelse (FAKTISKE)
Studieafslutning (FAKTISKE)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (SKØN)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (FAKTISKE)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LSS of 4-SITE
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 .