Resultatregister for bedre informeret behandling af atrieflimren (ORBIT-AF)
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Kontakter og lokationer
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater
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Dothan, Alabama, Forenede Stater
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Huntsville, Alabama, Forenede Stater
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Mobile, Alabama, Forenede Stater
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Montgomery, Alabama, Forenede Stater
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Pell City, Alabama, Forenede Stater
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Tuscaloosa, Alabama, Forenede Stater
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Arizona
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Cottonwood, Arizona, Forenede Stater
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Tucson, Arizona, Forenede Stater
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Arkansas
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Fort Smith, Arkansas, Forenede Stater
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California
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Carlsbad, California, Forenede Stater
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Carmichael, California, Forenede Stater
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Corona, California, Forenede Stater
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Laguna Hills, California, Forenede Stater
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Long Beach, California, Forenede Stater
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Los Alamitos, California, Forenede Stater
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Los Angeles, California, Forenede Stater
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Montebello, California, Forenede Stater
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Northridge, California, Forenede Stater
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Orange, California, Forenede Stater
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Oxnard, California, Forenede Stater
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Palo Alto, California, Forenede Stater
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Pismo Beach, California, Forenede Stater
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Pomona, California, Forenede Stater
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San Diego, California, Forenede Stater
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San Ramon, California, Forenede Stater
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Santa Rosa, California, Forenede Stater
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Tarzana, California, Forenede Stater
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Torrance, California, Forenede Stater
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Tustin, California, Forenede Stater
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Ventura, California, Forenede Stater
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Colorado
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Aurora, Colorado, Forenede Stater
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Colorado Springs, Colorado, Forenede Stater
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Golden, Colorado, Forenede Stater
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Delaware
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Newark, Delaware, Forenede Stater
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Seaford, Delaware, Forenede Stater
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Florida
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Boynton Beach, Florida, Forenede Stater
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Coral Springs, Florida, Forenede Stater
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Deerfield Beach, Florida, Forenede Stater
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Fort Myers, Florida, Forenede Stater
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Fort Walton Beach, Florida, Forenede Stater
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Hollywood, Florida, Forenede Stater
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Jupiter, Florida, Forenede Stater
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Lakeland, Florida, Forenede Stater
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Oakland Park, Florida, Forenede Stater
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Orange Park, Florida, Forenede Stater
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Ormond Beach, Florida, Forenede Stater
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Port Charlotte, Florida, Forenede Stater
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St. Petersburg, Florida, Forenede Stater
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Tallahassee, Florida, Forenede Stater
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Georgia
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Atlanta, Georgia, Forenede Stater
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Decatur, Georgia, Forenede Stater
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Marietta, Georgia, Forenede Stater
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Riverdale, Georgia, Forenede Stater
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Idaho
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Idaho Falls, Idaho, Forenede Stater
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Nampa, Idaho, Forenede Stater
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Illinois
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Aurora, Illinois, Forenede Stater
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Evergreen Park, Illinois, Forenede Stater
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Melrose Park, Illinois, Forenede Stater
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Peoria, Illinois, Forenede Stater
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Rock Island, Illinois, Forenede Stater
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Rockford, Illinois, Forenede Stater
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Urbana, Illinois, Forenede Stater
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Winfield, Illinois, Forenede Stater
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Indiana
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Bloomington, Indiana, Forenede Stater
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Evansville, Indiana, Forenede Stater
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Hammond, Indiana, Forenede Stater
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Indianapolis, Indiana, Forenede Stater
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La Porte, Indiana, Forenede Stater
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South Bend, Indiana, Forenede Stater
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Iowa
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Waterloo, Iowa, Forenede Stater
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Kansas
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Overland Park, Kansas, Forenede Stater
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Kentucky
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Crestview Hills, Kentucky, Forenede Stater
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Lexington, Kentucky, Forenede Stater
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Owensboro, Kentucky, Forenede Stater
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Louisiana
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Alexandria, Louisiana, Forenede Stater
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Maine
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Rockport, Maine, Forenede Stater
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Maryland
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Beltsville, Maryland, Forenede Stater
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Salisbury, Maryland, Forenede Stater
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Massachusetts
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Biddeford, Massachusetts, Forenede Stater
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Michigan
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Bay City, Michigan, Forenede Stater
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Bridgman, Michigan, Forenede Stater
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Commerce Township, Michigan, Forenede Stater
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Grand Blanc, Michigan, Forenede Stater
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Lansing, Michigan, Forenede Stater
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Livonia, Michigan, Forenede Stater
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Mount Clemens, Michigan, Forenede Stater
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Stevensville, Michigan, Forenede Stater
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Traverse City, Michigan, Forenede Stater
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Troy, Michigan, Forenede Stater
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Minnesota
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Minneapolis, Minnesota, Forenede Stater
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Montana
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Anaconda, Montana, Forenede Stater
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Nebraska
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Omaha, Nebraska, Forenede Stater
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Nevada
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Las Vegas, Nevada, Forenede Stater
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New Jersey
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Bridgewater, New Jersey, Forenede Stater
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Elmer, New Jersey, Forenede Stater
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Haddon Heights, New Jersey, Forenede Stater
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Linden, New Jersey, Forenede Stater
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Nampa, New Jersey, Forenede Stater
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Ridgewood, New Jersey, Forenede Stater
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Sewell, New Jersey, Forenede Stater
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Toms River, New Jersey, Forenede Stater
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New York
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Flushing, New York, Forenede Stater
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Huntington, New York, Forenede Stater
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Jamaica, New York, Forenede Stater
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New York, New York, Forenede Stater
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Northport, New York, Forenede Stater
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North Carolina
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Calabash, North Carolina, Forenede Stater
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Charlotte, North Carolina, Forenede Stater
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Durham, North Carolina, Forenede Stater
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Greenwood, North Carolina, Forenede Stater
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Jacksonville, North Carolina, Forenede Stater
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Pinehurst, North Carolina, Forenede Stater
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Raleigh, North Carolina, Forenede Stater
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Sanford, North Carolina, Forenede Stater
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Tabor City, North Carolina, Forenede Stater
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Winston Salem, North Carolina, Forenede Stater
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North Dakota
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Fargo, North Dakota, Forenede Stater
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Minot, North Dakota, Forenede Stater
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Ohio
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Mansfield, Ohio, Forenede Stater
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Miamisburg, Ohio, Forenede Stater
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Piqua, Ohio, Forenede Stater
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Toledo, Ohio, Forenede Stater
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Worthington, Ohio, Forenede Stater
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Youngstown, Ohio, Forenede Stater
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Pennsylvania
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Abington, Pennsylvania, Forenede Stater
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Beaver, Pennsylvania, Forenede Stater
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Danville, Pennsylvania, Forenede Stater
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Doylestown, Pennsylvania, Forenede Stater
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Erie, Pennsylvania, Forenede Stater
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Lansdale, Pennsylvania, Forenede Stater
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Philadelphia, Pennsylvania, Forenede Stater
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Scranton, Pennsylvania, Forenede Stater
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Spring House, Pennsylvania, Forenede Stater
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West Reading, Pennsylvania, Forenede Stater
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Wynnewood, Pennsylvania, Forenede Stater
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Yardley, Pennsylvania, Forenede Stater
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Rhode Island
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Pawtucket, Rhode Island, Forenede Stater
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South Carolina
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Anderson, South Carolina, Forenede Stater
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Easley, South Carolina, Forenede Stater
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Spartanburg, South Carolina, Forenede Stater
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Tennessee
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Harriman, Tennessee, Forenede Stater
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Kingsport, Tennessee, Forenede Stater
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Nashville, Tennessee, Forenede Stater
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Texas
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Arlington, Texas, Forenede Stater
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Beaumont, Texas, Forenede Stater
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Corpus Christi, Texas, Forenede Stater
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Flower Mound, Texas, Forenede Stater
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Fort Worth, Texas, Forenede Stater
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Houston, Texas, Forenede Stater
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Mcallen, Texas, Forenede Stater
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Odessa, Texas, Forenede Stater
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Plano, Texas, Forenede Stater
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San Antonio, Texas, Forenede Stater
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Tomball, Texas, Forenede Stater
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Utah
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Salt Lake City, Utah, Forenede Stater
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Virginia
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Fredericksburg, Virginia, Forenede Stater
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Lynchburg, Virginia, Forenede Stater
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Midlothian, Virginia, Forenede Stater
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Roanoke, Virginia, Forenede Stater
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Winchester, Virginia, Forenede Stater
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Washington
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Burien, Washington, Forenede Stater
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Port Orchard, Washington, Forenede Stater
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Spokane, Washington, Forenede Stater
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Tacoma, Washington, Forenede Stater
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Vancouver, Washington, Forenede Stater
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Wisconsin
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La Crosse, Wisconsin, Forenede Stater
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Madison, Wisconsin, Forenede Stater
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Hato Rey, Puerto Rico
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Rio Grande, Puerto Rico
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San Juan, Puerto Rico
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:
- Voksne patienter med hændelse (indledende diagnose) eller udbredt (eksisterende diagnose) AF med elektrokardiografisk dokumentation
- forventet evne til at overholde lokale regelmæssige planlagte opfølgningsbesøg
Ekskluderingskriterier:
- Forventet levetid mindre end 6 måneder
- kortvarig AF sekundær til en reversibel tilstand (f.eks. hyperthyroidisme, lungeemboli, post-kardiotorakal kirurgi)
- Deltagelse i et randomiseret forsøg med antikoagulering for AF på tidspunktet for indskrivning
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Antal grupper/kohorter
Kohorter og interventioner
Gruppe / kohorteGruppe / kohorte |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
001
Patienter med atrieflimren (AF) Behandlingsmønstre for AF i henhold til patientdemografiske kliniske faktorer risikerer stratificering og geografiske regioner.
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Behandlingsmønstre for AF i henhold til patientdemografi, kliniske faktorer, risikostratificering og geografiske regioner.
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Det primære resultat er slagtilfælde eller ikke-CNS (systemisk) emboli. Hovedformålet er: karakterisere og beskrive AF-patientpopulationen som helhed med vægt på demografi, komorbiditeter og risikoprofiler.
Tidsramme: 3 år
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3 år
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Antallet af alvorlige uønskede hjertehændelser.
Tidsramme: 3 år
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3 år
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Publikationer og nyttige links
Generelle publikationer
- Fox KAA, Virdone S, Pieper KS, Bassand JP, Camm AJ, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Kayani G, Oto A, Misselwitz F, Piccini JP, Dalgaard F, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. GARFIELD-AF risk score for mortality, stroke, and bleeding within 2 years in patients with atrial fibrillation. Eur Heart J Qual Care Clin Outcomes. 2022 Mar 2;8(2):214-227. doi: 10.1093/ehjqcco/qcab028.
- Steinberg BA, Holmes DN, Pieper K, Allen LA, Chan PS, Ezekowitz MD, Freeman JV, Fonarow GC, Gersh BJ, Hylek EM, Kowey PR, Mahaffey KW, Naccarelli G, Reiffel J, Singer DE, Peterson ED, Piccini JP; ORBIT-AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) Investigators and Patients. Factors Associated With Large Improvements in Health-Related Quality of Life in Patients With Atrial Fibrillation: Results From ORBIT-AF. Circ Arrhythm Electrophysiol. 2020 May;13(5):e007775. doi: 10.1161/CIRCEP.119.007775. Epub 2020 Apr 16.
- Holmes DN, Piccini JP, Allen LA, Fonarow GC, Gersh BJ, Kowey PR, O'Brien EC, Reiffel JA, Naccarelli GV, Ezekowitz MD, Chan PS, Singer DE, Spertus JA, Peterson ED, Thomas L. Defining Clinically Important Difference in the Atrial Fibrillation Effect on Quality-of-Life Score. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005358. doi: 10.1161/CIRCOUTCOMES.118.005358.
- Thind M, Holmes DN, Badri M, Pieper KS, Singh A, Blanco RG, Steinberg BA, Fonarow GC, Gersh BJ, Mahaffey KW, Peterson ED, Reiffel JA, Piccini JP, Kowey PR; ORBIT-AF Investigators and Patients. Embolic and Other Adverse Outcomes in Symptomatic Versus Asymptomatic Patients With Atrial Fibrillation (from the ORBIT-AF Registry). Am J Cardiol. 2018 Nov 15;122(10):1677-1683. doi: 10.1016/j.amjcard.2018.07.045. Epub 2018 Aug 20.
- Durheim MT, Holmes DN, Blanco RG, Allen LA, Chan PS, Freeman JV, Fonarow GC, Go AS, Hylek EM, Mahaffey KW, Pokorney SD, Reiffel JA, Singer DE, Peterson ED, Piccini JP. Characteristics and outcomes of adults with chronic obstructive pulmonary disease and atrial fibrillation. Heart. 2018 Nov;104(22):1850-1858. doi: 10.1136/heartjnl-2017-312735. Epub 2018 Jun 6.
- O'Brien EC, Holmes DN, Thomas LE, Fonarow GC, Allen LA, Gersh BJ, Kowey PR, Singer DE, Ezekowitz MD, Naccarelli GV, Ansell JE, Chan PS, Mahaffey KW, Go AS, Freeman JV, Reiffel JA, Peterson ED, Piccini JP, Hylek EM. Prognostic Significance of Nuisance Bleeding in Anticoagulated Patients With Atrial Fibrillation. Circulation. 2018 Aug 28;138(9):889-897. doi: 10.1161/CIRCULATIONAHA.117.031354.
- Fox KAA, Lucas JE, Pieper KS, Bassand JP, Camm AJ, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Kayani G, Oto A, Mantovani LG, Misselwitz F, Piccini JP, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. Improved risk stratification of patients with atrial fibrillation: an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation. BMJ Open. 2017 Dec 21;7(12):e017157. doi: 10.1136/bmjopen-2017-017157.
- Piccini JP, Simon DN, Steinberg BA, Thomas L, Allen LA, Fonarow GC, Gersh B, Hylek E, Kowey PR, Reiffel JA, Naccarelli GV, Chan PS, Spertus JA, Peterson ED; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and Patients. Differences in Clinical and Functional Outcomes of Atrial Fibrillation in Women and Men: Two-Year Results From the ORBIT-AF Registry. JAMA Cardiol. 2016 Jun 1;1(3):282-91. doi: 10.1001/jamacardio.2016.0529.
- Golwala H, Jackson LR 2nd, Simon DN, Piccini JP, Gersh B, Go AS, Hylek EM, Kowey PR, Mahaffey KW, Thomas L, Fonarow GC, Peterson ED, Thomas KL; Outcomes Registry for Better Informed Treatment for Atrial Fibrillation (ORBIT-AF) Registry. Racial/ethnic differences in atrial fibrillation symptoms, treatment patterns, and outcomes: Insights from Outcomes Registry for Better Informed Treatment for Atrial Fibrillation Registry. Am Heart J. 2016 Apr;174:29-36. doi: 10.1016/j.ahj.2015.10.028. Epub 2015 Dec 30.
- Jackson LR 2nd, Kim SH, Piccini JP Sr, Gersh BJ, Naccarelli GV, Reiffel JA, Freeman J, Thomas L, Chang P, Fonarow GC, Go AS, Mahaffey KW, Peterson ED, Kowey PR. Sinus Node Dysfunction Is Associated With Higher Symptom Burden and Increased Comorbid Illness: Results From the ORBIT-AF Registry. Clin Cardiol. 2016 Feb;39(2):119-25. doi: 10.1002/clc.22504. Epub 2015 Dec 31.
- Steinberg BA, Kim S, Thomas L, Fonarow GC, Gersh BJ, Holmqvist F, Hylek E, Kowey PR, Mahaffey KW, Naccarelli G, Reiffel JA, Chang P, Peterson ED, Piccini JP; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and Patients. Increased Heart Rate Is Associated With Higher Mortality in Patients With Atrial Fibrillation (AF): Results From the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF). J Am Heart Assoc. 2015 Sep 14;4(9):e002031. doi: 10.1161/JAHA.115.002031.
- Holmqvist F, Simon D, Steinberg BA, Hong SJ, Kowey PR, Reiffel JA, Naccarelli GV, Chang P, Gersh BJ, Peterson ED, Piccini JP; ORBIT-AF Investigators. Catheter Ablation of Atrial Fibrillation in U.S. Community Practice--Results From Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). J Am Heart Assoc. 2015 May 21;4(5):e001901. doi: 10.1161/JAHA.115.001901.
- Holmqvist F, Guan N, Zhu Z, Kowey PR, Allen LA, Fonarow GC, Hylek EM, Mahaffey KW, Freeman JV, Chang P, Holmes DN, Peterson ED, Piccini JP, Gersh BJ; ORBIT-AF Investigators. Impact of obstructive sleep apnea and continuous positive airway pressure therapy on outcomes in patients with atrial fibrillation-Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Am Heart J. 2015 May;169(5):647-654.e2. doi: 10.1016/j.ahj.2014.12.024. Epub 2015 Feb 7.
- Steinberg BA, Peterson ED, Kim S, Thomas L, Gersh BJ, Fonarow GC, Kowey PR, Mahaffey KW, Sherwood MW, Chang P, Piccini JP, Ansell J; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation Investigators and Patients. Use and outcomes associated with bridging during anticoagulation interruptions in patients with atrial fibrillation: findings from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Circulation. 2015 Feb 3;131(5):488-94. doi: 10.1161/CIRCULATIONAHA.114.011777. Epub 2014 Dec 12.
- Steinberg BA, Kim S, Fonarow GC, Thomas L, Ansell J, Kowey PR, Mahaffey KW, Gersh BJ, Hylek E, Naccarelli G, Go AS, Reiffel J, Chang P, Peterson ED, Piccini JP. Drivers of hospitalization for patients with atrial fibrillation: Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Am Heart J. 2014 May;167(5):735-42.e2. doi: 10.1016/j.ahj.2014.02.003. Epub 2014 Feb 17.
- Steinberg BA, Kim S, Thomas L, Fonarow GC, Hylek E, Ansell J, Go AS, Chang P, Kowey P, Gersh BJ, Mahaffey KW, Singer DE, Piccini JP, Peterson ED; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and Patients. Lack of concordance between empirical scores and physician assessments of stroke and bleeding risk in atrial fibrillation: results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry. Circulation. 2014 May 20;129(20):2005-12. doi: 10.1161/CIRCULATIONAHA.114.008643. Epub 2014 Mar 29.
- Steinberg BA, Holmes DN, Piccini JP, Ansell J, Chang P, Fonarow GC, Gersh B, Mahaffey KW, Kowey PR, Ezekowitz MD, Singer DE, Thomas L, Peterson ED, Hylek EM; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and Patients. Early adoption of dabigatran and its dosing in US patients with atrial fibrillation: results from the outcomes registry for better informed treatment of atrial fibrillation. J Am Heart Assoc. 2013 Nov 25;2(6):e000535. doi: 10.1161/JAHA.113.000535.
- Steinberg BA, Kim S, Piccini JP, Fonarow GC, Lopes RD, Thomas L, Ezekowitz MD, Ansell J, Kowey P, Singer DE, Gersh B, Mahaffey KW, Hylek E, Go AS, Chang P, Peterson ED; ORBIT-AF Investigators and Patients. Use and associated risks of concomitant aspirin therapy with oral anticoagulation in patients with atrial fibrillation: insights from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Registry. Circulation. 2013 Aug 13;128(7):721-8. doi: 10.1161/CIRCULATIONAHA.113.002927. Epub 2013 Jul 16.
- Piccini JP, Fraulo ES, Ansell JE, Fonarow GC, Gersh BJ, Go AS, Hylek EM, Kowey PR, Mahaffey KW, Thomas LE, Kong MH, Lopes RD, Mills RM, Peterson ED. Outcomes registry for better informed treatment of atrial fibrillation: rationale and design of ORBIT-AF. Am Heart J. 2011 Oct;162(4):606-612.e1. doi: 10.1016/j.ahj.2011.07.001.
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- CR016327
- RIVAROXAFL4001 (Anden identifikator: Janssen Scientific Affairs, LLC)
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