Lead Registry for Optim Leads (OPTIMUM)
7. maj 2021 opdateret af: Abbott Medical Devices
Optim Lead Insulation Material Registry
This is a prospective, multi-center, actively monitored, long term data collection registry.
Any Patient that receives a market released St. Jude Medical (SJM) Optim lead and a compatible market released cardia rhythm management (CRM) implantable pulse generator is eligible for enrollment into the registry.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Patients are enrolled in the registry up to 180 days post implantation of an Optim lead. Patients with Optim™ ICD leads and Quicksite®/Quickflex®/Quickflex® µ/Quartet® LV leads are followed indefinitely following enrollment. Patients with other Optim leads are followed for a period of 60 months after Optim™ lead implantation. The follow-up plan for this registry is based on the established follow-up practices currently used by each of the respective registry centers. Patients are followed according to the center's standard follow-up schedule.
At each office/clinic follow-up visit standard electrical measurements are collected. During system revision in a patient with either Optim™ ICD leads, Quicksite®, Quickflex®, Quickflex® µ or Quartet® LV lead, cinefluoroscopy (AP, LAO 45° or the best possible LAO view, RAO 45° or the best possible RAO view) should be performed at specific study sites. If cinefluoroscopy or chest X-ray is performed according to the site's standard of care then copies of those should be submitted.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
14124
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Liège, Belgien, 4000
- CHR Citadelle
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Alabama
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Alabaster, Alabama, Forenede Stater, 35007
- Heart South Cardiovascular Group PC
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Fort Payne, Alabama, Forenede Stater, 35968
- Appalachian Cardiovascular Associates
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Gadsden, Alabama, Forenede Stater, 35903
- North Alabama Cardiology Center
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Mobile, Alabama, Forenede Stater, 36608
- Cardiology Associates of Mobile, Inc.
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
- Alaska Heart Institute
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Arizona
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Tucson, Arizona, Forenede Stater, 85723
- Southern Arizona VA Health Care System
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Tucson, Arizona, Forenede Stater, 85712
- Pima Heart Physicians, PC
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Arkansas Cardiology
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Little Rock, Arkansas, Forenede Stater, 72211
- *Little Rock Cardiology Clinic
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Springdale, Arkansas, Forenede Stater, 72764
- Northwest Cardiology
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California
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Beverly Hills, California, Forenede Stater, 90211
- Westside Cardiovascular Associates
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Burbank, California, Forenede Stater, 91505
- Raymond Schaerf, MD
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Burlingame, California, Forenede Stater, 94010
- Mills-Peninsula Cardiovascular Specialists
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Encino, California, Forenede Stater, 91436
- Center for Interventional Cardiology and Nephrology
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Fresno, California, Forenede Stater, 93650
- Cardiac Institute
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Fresno, California, Forenede Stater, 93720
- Mid Valley Cardiology
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Glendale, California, Forenede Stater, 91204
- Glendale Memorial Hospital and Medical Center
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Glendale, California, Forenede Stater, 91203
- Cardiac Care Specialists
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Inglewood, California, Forenede Stater, 90301
- Apex Cardiology
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Lakewood, California, Forenede Stater, 90712
- Kartik Thaker, MD Inc.
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Los Alamitos, California, Forenede Stater, 90720
- Omid Vahdat M.D.
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Los Angeles, California, Forenede Stater, 90048
- Jeffrey Goodman MD
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Los Angeles, California, Forenede Stater, 90048
- Donna Gallik MD
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Los Angeles, California, Forenede Stater, 90067
- Payam Yashar M.D.
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Mission Viejo, California, Forenede Stater, 92691
- Stephen S. Ehrlich, MD
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Murrieta, California, Forenede Stater, 95263
- Inland Valley Cardiovascular Center
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Northridge, California, Forenede Stater, 91325
- Mehrdad Ariani MD
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Northridge, California, Forenede Stater, 91325
- Soltera Yasuda & Associates
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Oxnard, California, Forenede Stater, 93030
- Cabrillo Cardiology Medical Group
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Oxnard, California, Forenede Stater, 93036
- Alejandro Garcia MD
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Palm Springs, California, Forenede Stater, 92262
- Desert Heart Physicians
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Pasadena, California, Forenede Stater, 91105
- Southern California Heart Specialists
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Rancho Mirage, California, Forenede Stater, 92270
- William A Stellar, MD
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Reseda, California, Forenede Stater, 91335
- Cardiac Rhythm Specialists, Inc.
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Riverside, California, Forenede Stater, 34232
- Heart Center of Riverside
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Sacramento, California, Forenede Stater, 95816
- Mercy Medical Group Cardiology
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Salinas, California, Forenede Stater, 93901
- Salinas Valley Memorial Hospital
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Santa Maria, California, Forenede Stater, 93454
- Bruce A. Ourieff MD
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Sun City, California, Forenede Stater, 92586
- Sun City Cardiology Medical Center, Incorporated
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Sun City, California, Forenede Stater, 92586
- Sun City Cardiology Medical Center, Inc
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Tarzana, California, Forenede Stater, 91356
- Michael Burnam, MD
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Tarzana, California, Forenede Stater, 91356
- Richard P. Cain, MD
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Torrance, California, Forenede Stater, 90505
- COR Healthcare Medical Associates
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Van Nuys, California, Forenede Stater, 91405
- Cardiovascular Consultants
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Van Nuys, California, Forenede Stater, 91406
- Arash Vahdat, MD
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Wildomar, California, Forenede Stater, 92595
- Shiva Heart Center Medical Group
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Yuba City, California, Forenede Stater, 95991
- Feather River Cardiovascular Institute
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Yuba City, California, Forenede Stater, 95991
- Yuba Sutter Medical Clinic
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80909
- Pikes Peak Cardiology
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Colorado Springs, Colorado, Forenede Stater, 80907
- Penrose St. Francis Cardiology Associates PC
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Denver, Colorado, Forenede Stater, 80210
- Harvard Park Medical
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Littleton, Colorado, Forenede Stater, 80120
- South Denver Cardiology Associates PC
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Connecticut
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New Britain, Connecticut, Forenede Stater, 06052
- Grove Hill Medical Center
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Norwalk, Connecticut, Forenede Stater, 06851
- Cardiology Associates of Fairfield County, PC
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Florida
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Boca Raton, Florida, Forenede Stater, 33422
- Cardiac Arrhythmia Services
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Bradenton, Florida, Forenede Stater, 34209
- Bradenton Heart Center
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Brandon, Florida, Forenede Stater, 33511
- Bay Area Cardiology Associates PA
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Brooksville, Florida, Forenede Stater, 34613
- Florida Cardiology Group
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Clearwater, Florida, Forenede Stater, 33756
- Pinellas Arrhythmia Associates
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Crestview, Florida, Forenede Stater, 32539
- Okaloosa Heart and Vascular
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Daytona Beach, Florida, Forenede Stater, 32114
- Cardiology Consultants PA
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Delray Beach, Florida, Forenede Stater, 33484
- The Cardiology Center, Incorporated
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Fort Walton Beach, Florida, Forenede Stater, 32547
- White-Wilson Medical Center - Fort Walton Beach
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Gainesville, Florida, Forenede Stater, 32610
- Shands at the University of Florida
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Gainesville, Florida, Forenede Stater, 32605
- The Cardiac & Vascular Institute Research Foundation, LLC
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Hollywood, Florida, Forenede Stater, 33021
- Florida Institute for Cardiovascular Care
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Lake Mary, Florida, Forenede Stater, 32746
- Jorge Diaz, M.D., P.A.
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Lakeland, Florida, Forenede Stater, 33806-2098
- Clark & Daughtrey Medical Group, PA
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Melbourne, Florida, Forenede Stater, 32901
- Melbourne Internal Medicine Associates
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Melbourne, Florida, Forenede Stater, 32901
- Diagnostic and Interventional Cardiology
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Miami Beach, Florida, Forenede Stater, 33140
- Miami International Cardiology Consultants Inc
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Ocala, Florida, Forenede Stater, 34474
- Central Florida Heart Center
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Ocala, Florida, Forenede Stater, 34471
- Institute of Cardiovascular Research LLC
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Ocala, Florida, Forenede Stater, 34471
- Ram Vasudevan, MD, FACC
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Orlando, Florida, Forenede Stater, 32803
- Cardiovascular Interventions, P.A.
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Orlando, Florida, Forenede Stater, 32806
- Mid-Florida Cardiology Specialist
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Ormond Beach, Florida, Forenede Stater, 32174
- Cardiology Research Associates
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Palatka, Florida, Forenede Stater, 32177
- Cardio Care Center
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Saint Augustine, Florida, Forenede Stater, 32086
- St. Augustine Cardiology Associates
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Sarasota, Florida, Forenede Stater, 34232
- Heart Care Research
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Sarasota, Florida, Forenede Stater, 34239
- Sarasota Heart Center
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Sarasota, Florida, Forenede Stater, 34321
- Sarasota Arrhythmia Institute
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Summerfield, Florida, Forenede Stater, 34491
- Dr. Kalpesh Solanki
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Tallahassee, Florida, Forenede Stater, 32308
- Tallahassee Research Institute
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Tamarac, Florida, Forenede Stater, 33321
- Mazhar Majid, M.D.
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Venice, Florida, Forenede Stater, 34292
- Heart & Vascular Center of Venice
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Georgia
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Athens, Georgia, Forenede Stater, 30606
- Piedmont Athens Regional Medical Center
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Athens, Georgia, Forenede Stater, 30606
- Athens Heart Center
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Athens, Georgia, Forenede Stater, 30606
- St. Mary's
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Atlanta, Georgia, Forenede Stater, 30309
- Piedmont Heart Institute - Buckhead Location
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Gainesville, Georgia, Forenede Stater, 30501
- Northeast Georgia Heart Foundation
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Lawrenceville, Georgia, Forenede Stater, 30045
- Gwinnet Consultants in Cardiology
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Marietta, Georgia, Forenede Stater, 30060
- Kennestone Heart Physicians
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Rome, Georgia, Forenede Stater, 30165
- Harbin Clinic Southeastern Cardiovascular Institute
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Valdosta, Georgia, Forenede Stater, 31602
- South Georgia Cardiology PC
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Illinois
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Aurora, Illinois, Forenede Stater, 60504
- Fox Valley Cardiovascular Consultants
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Elgin, Illinois, Forenede Stater, 60123
- Provena Saint Joseph Hospital
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Oak Lawn, Illinois, Forenede Stater, 60453
- MidAmerica Cardiovascular Consultants
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Rockford, Illinois, Forenede Stater, 61107
- Rockford Cardiology Associates
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Indiana
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Evansville, Indiana, Forenede Stater, 47714
- Ohio Valley Heart Care
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Hammond, Indiana, Forenede Stater, 46320
- Saint Margaret Mercy Healthcare Centers
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Jeffersonville, Indiana, Forenede Stater, 47130
- River Cities Cardiology
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Muncie, Indiana, Forenede Stater, 47303
- Medical Consultants
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Munster, Indiana, Forenede Stater, 46321
- Cardiology Associates of NW Indiana
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Iowa
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Des Moines, Iowa, Forenede Stater, 50316
- Unitypoint
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Kentucky
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Ashland, Kentucky, Forenede Stater, 41101
- Cumberland Cardiology
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Lexington, Kentucky, Forenede Stater, 40504
- Cardiology Associates of Kentucky
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Louisville, Kentucky, Forenede Stater, 40215
- Bluegrass Cardiology
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Madisonville, Kentucky, Forenede Stater, 42431
- Baptist Health Medical Group, Inc.
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Louisiana
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Alexandria, Louisiana, Forenede Stater, 71301
- Alexandria Cardiology Clinic
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Alexandria, Louisiana, Forenede Stater, 71301
- Freedman Memorial Cardiology
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Baton Rouge, Louisiana, Forenede Stater, 70808
- Our Lady of the Lake Hospital
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Covington, Louisiana, Forenede Stater, 70433
- Cardiovascular Associates
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Covington, Louisiana, Forenede Stater, 70433
- Covington Cardiovascular Care
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Covington, Louisiana, Forenede Stater, 70433
- St. Tammany Heart and Vascular
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Lacombe, Louisiana, Forenede Stater, 70445
- Heart and Vascular Institute of LA LLC
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Lafayette, Louisiana, Forenede Stater, 70503
- Mike Mounir MD
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Lake Charles, Louisiana, Forenede Stater, 70601
- Imperial Health, LLP
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Lake Charles, Louisiana, Forenede Stater, 70601
- Cardiovascular Specialists of SWLA
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Marrero, Louisiana, Forenede Stater, 70072
- Cardiology Center
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Monroe, Louisiana, Forenede Stater, 71201
- Gregory C. Sampognaro Interventional Cardiology
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Shreveport, Louisiana, Forenede Stater, 71105
- Cardiology Associates Incorporated
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Maine
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Bangor, Maine, Forenede Stater, 04401
- Eastern Maine Medical Center
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Maryland
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Bethesda, Maryland, Forenede Stater, 20889
- National Naval Medical Center
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Rockville, Maryland, Forenede Stater, 20850
- Cardiac Associates PC
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Salisbury, Maryland, Forenede Stater, 21804
- Peninsula Cardiology Associates, P.A.
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Salisbury, Maryland, Forenede Stater, 21804
- Delmarva Heart
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Silver Spring, Maryland, Forenede Stater, 20902
- Alan Schneider
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Massachusetts
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Florence, Massachusetts, Forenede Stater, 01062
- Baystate Medical Practice
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Hyannis, Massachusetts, Forenede Stater, 02601
- The Cardiovascular Specialists
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Worcester, Massachusetts, Forenede Stater, 01655
- University of Massachusetts Medical Center
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Worcester, Massachusetts, Forenede Stater, 01608
- Fallon Clinic
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Worcester, Massachusetts, Forenede Stater, 01608
- Heart Rhythm Specialists of Central Massachusetts, PC
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Michigan
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Birmingham, Michigan, Forenede Stater, 48009
- Cardiology and Arrhythmia Consultants P.C.
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Grand Blanc, Michigan, Forenede Stater, 48439
- Regional Cardiology Associates, PLC
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Rochester Hills, Michigan, Forenede Stater, 48307
- Academic Cardiology Associates
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Southfield, Michigan, Forenede Stater, 48075
- Heart Cardiology Consultants
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Traverse City, Michigan, Forenede Stater, 49684
- Grand Traverse Heart Associates
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Warren, Michigan, Forenede Stater, 48093
- Lingareddy Devireddy, PC
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55802
- St. Luke's Cardiology Associates
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Minneapolis, Minnesota, Forenede Stater, 55417
- VA Medical Center Minneapolis
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota Medical Center Fairview
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Mississippi
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Biloxi, Mississippi, Forenede Stater, 39532
- Coast Cardiovascular Consultants
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Gulfport, Mississippi, Forenede Stater, 39503
- Coast Cardiology Center
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Hattiesburg, Mississippi, Forenede Stater, 39401
- Hattiesburg Clinic
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Missouri
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Cape Girardeau, Missouri, Forenede Stater, 63703
- Cardiovascular Consultants of Cape Girardeau Inc
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Florissant, Missouri, Forenede Stater, 63031
- The Heart Care Group
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Kansas City, Missouri, Forenede Stater, 64111
- Cardiovascular Consultants (now St. Luke's)
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Saint Louis, Missouri, Forenede Stater, 63110
- St. Louis University Hospital
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Saint Louis, Missouri, Forenede Stater, 63128
- County Cardiology, Inc.
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Saint Louis, Missouri, Forenede Stater, 63141-6835
- The Heart Health Center
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Saint Louis, Missouri, Forenede Stater, 63146
- St. Louis Cardiology Consultants
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68198
- University of Nebraska Medical Center
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Omaha, Nebraska, Forenede Stater, 68114
- Methodist Physicians Clinic-Heart Consultants
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Omaha, Nebraska, Forenede Stater, 68124
- Alegent Creighton Health
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89109
- Nevada Cardiology Associates
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New Jersey
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Camden, New Jersey, Forenede Stater, 08103
- Cooper University Hospital
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Cherry Hill, New Jersey, Forenede Stater, 08002
- South Jersey Heart Group
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Flemington, New Jersey, Forenede Stater, 08822
- Hunterdon Cardiovascular Associates
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Hamilton, New Jersey, Forenede Stater, 08690
- Hamilton Cardiology Associates
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Morristown, New Jersey, Forenede Stater, 07962
- Atlantic Health System - Morristown Memorial Hospital
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Ocean City, New Jersey, Forenede Stater, 07712
- Monmouth Cardiology Associates, LLC
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Wayne, New Jersey, Forenede Stater, 07470
- Cardiology Consultants of North Jersey
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West Orange, New Jersey, Forenede Stater, 07052
- New Jersey Cardiology Associates
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
- New Mexico Heart Institute
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New York
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Glens Falls, New York, Forenede Stater, 12801
- Adirondack Cardiology Associates
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Mineola, New York, Forenede Stater, 11501
- Long Island Heart Associates
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Roslyn, New York, Forenede Stater, 11576
- Cardiac Arrhythmia and Pacemaker Center
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North Carolina
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Goldsboro, North Carolina, Forenede Stater, 27534
- Wayne Heart Internal Medicine
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Hickory, North Carolina, Forenede Stater, 28602
- Piedmont Cardiology Associates
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Raleigh, North Carolina, Forenede Stater, 27610
- Wake Heart Associates
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58112
- Sanford Research
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Grand Forks, North Dakota, Forenede Stater, 58201
- Altru Clinic - Main
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Ohio
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Barberton, Ohio, Forenede Stater, 44203
- City Cardiology Associates
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Columbus, Ohio, Forenede Stater, 43222
- Electrophysiology & Pacing Interventionalists
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Columbus, Ohio, Forenede Stater, 43222
- Electrophysiology and Pacing Interventionalists
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Elyria, Ohio, Forenede Stater, 44035
- University Hospitals Elyria Medical Center
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Fairfield, Ohio, Forenede Stater, 45014
- Mercy Hospital Fairfield
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Springfield, Ohio, Forenede Stater, 45504
- Ohio Institute Of Cardiac Care
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Steubenville, Ohio, Forenede Stater, 43952
- Heart Care Cardiology Consultants, Inc.
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Steubenville, Ohio, Forenede Stater, 43952
- Riverside Medical of Ohio
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Toledo, Ohio, Forenede Stater, 43623
- Toledo Clinic
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Toledo, Ohio, Forenede Stater, 43615
- Northwest Ohio Cardiology Consultants
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Youngstown, Ohio, Forenede Stater, 44504
- Ohio Heart Institute
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Youngstown, Ohio, Forenede Stater, 44505
- Cardiac Arrhythmia Associates
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73112
- Khastgir, Terrance M.D.
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Tulsa, Oklahoma, Forenede Stater, 74136
- Cardiovascular Consultants, Inc.
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Pennsylvania
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Abington, Pennsylvania, Forenede Stater, 19001
- Abington Medical Specialists
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Butler, Pennsylvania, Forenede Stater, 16001
- SouthWestern Pennsylvania Cardiovascular Associates
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Hospital of the University of Pennsylvania
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Sandy, Pennsylvania, Forenede Stater, 15801
- Dubois Regional Cardiology Associates
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Sayre, Pennsylvania, Forenede Stater, 18840
- Donald Guthrie Foundation for Education and Research
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
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Charleston, South Carolina, Forenede Stater, 29403
- Charleston Cardiology
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Charleston, South Carolina, Forenede Stater, 29407
- Coastal Cardiology
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Columbia, South Carolina, Forenede Stater, 29204
- South Carolina Heart Center
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Florence, South Carolina, Forenede Stater, 29506
- Pee Dee Cardiology Associates, PA
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Greenwood, South Carolina, Forenede Stater, 29646
- Piedmont Cardiology
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37404
- The Chattanooga Heart Institute
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Johnson City, Tennessee, Forenede Stater, 37601
- Mountain States Medical Group Cardiology
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Knoxville, Tennessee, Forenede Stater, 37922
- Knoxville Cardiovascular Research Group, LLC
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Knoxville, Tennessee, Forenede Stater, 37920
- East Tennessee Heart Consultants - Knoxville
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Memphis, Tennessee, Forenede Stater, 38104
- Arrhythmia Consultants, P.C.
-
-
Texas
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Austin, Texas, Forenede Stater, 78705
- Heart Rhythm Consultants
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Bay City, Texas, Forenede Stater, 77404
- Bay City Cardiology Clinic at Matagorda General Hospital
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Beaumont, Texas, Forenede Stater, 77702
- Southeast Texas Cardiology
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College Station, Texas, Forenede Stater, 77845
- BCS Heart, LLP
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Dallas, Texas, Forenede Stater, 75390-9016
- University of Texas Southwestern Medical Center at Dallas
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Dallas, Texas, Forenede Stater, 75230
- Dallas Heart Group
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Dallas, Texas, Forenede Stater, 75231-3833
- North Texas Heart Center
-
El Paso, Texas, Forenede Stater, 79936
- Cardiology Care Consultants
-
Fort Worth, Texas, Forenede Stater, 76104
- Texas Heart Clinic, PA
-
Houston, Texas, Forenede Stater, 77030
- Willowbrook Cardiovascular Associates
-
Houston, Texas, Forenede Stater, 77030
- Center for Cardiac Arrhythmias
-
Houston, Texas, Forenede Stater, 77030
- EP/Cardiology PA
-
Humble, Texas, Forenede Stater, 77338
- Cardiovascular Association, P.L.L.C.
-
Lubbock, Texas, Forenede Stater, 79410
- Texas Cardiac Center
-
Midland, Texas, Forenede Stater, 79761
- Permian Cardiology Associates
-
Odessa, Texas, Forenede Stater, 79761
- Odessa Heart Institute, P. A.
-
Orange, Texas, Forenede Stater, 77630
- Miguel E. Castellanos, MD
-
San Antonio, Texas, Forenede Stater, 78201
- South Texas Cardiovascular Consultants
-
San Antonio, Texas, Forenede Stater, 78229
- Cardiology Clinic Of San Antonio Pa
-
San Antonio, Texas, Forenede Stater, 78234
- Brooke Army Medical Center, Division of Cardiology
-
Temple, Texas, Forenede Stater, 76508
- Scott & White Memorial Hospital
-
Tyler, Texas, Forenede Stater, 75701
- Cardiovascular Associates of East Texas
-
Victoria, Texas, Forenede Stater, 77901
- Victoria Heart and Vascular
-
-
Virginia
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Chesapeake, Virginia, Forenede Stater, 23320
- Cardiovascular Associates Ltd
-
Fairfax, Virginia, Forenede Stater, 22031
- The Cardiovascular Group
-
Falls Church, Virginia, Forenede Stater, 22042
- Inova Fairfax Hospital
-
Hampton, Virginia, Forenede Stater, 23666
- Riverside Heart Specialists
-
Harrisonburg, Virginia, Forenede Stater, 22801
- Harrisonburg Medical Associations, Inc.
-
Richmond, Virginia, Forenede Stater, 23229
- Virginia Cardiovascular Specialists
-
Richmond, Virginia, Forenede Stater, 23249
- Hunter Holmes McGuire VAMC
-
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Washington
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Bellevue, Washington, Forenede Stater, 98004
- Overlake Internal Medicine Associates
-
Bellevue, Washington, Forenede Stater, 98004
- Bellevue Cardiology
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Bremerton, Washington, Forenede Stater, 98310
- Kitsap Cardiology Consultants
-
Mount Vernon, Washington, Forenede Stater, 98274
- Skagit Valley Medical Center
-
Seattle, Washington, Forenede Stater, 98111
- The Heart Institute at Virginia Mason
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Spokane, Washington, Forenede Stater, 99202
- Sacred Heart Medical Center
-
Spokane, Washington, Forenede Stater, 99204
- Kootenai Heart Clinics
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Tacoma, Washington, Forenede Stater, 98405
- Franciscan Heart & Vascular Associates
-
Tacoma, Washington, Forenede Stater, 98405
- Franciscan Cardiology Associates
-
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Wisconsin
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Green Bay, Wisconsin, Forenede Stater, 54301-3528
- Cardiology Associates of Green Bay, Ltd.
-
Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Hospital and Clinics
-
Madison, Wisconsin, Forenede Stater, 53715
- Dean Foundation
-
-
-
-
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Hamberg, Tyskland, 20099
- Asklepios Klinik St. Georg
-
Hamberg, Tyskland, 22417
- Asklepios Klinik Nord Heidberg-Ochsenzoll
-
Hamberg, Tyskland, 22763
- Asklepios Klinik Altona
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Hamburg, Tyskland, 20095
- Praxis Dr. med. Subin
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Bad-wur
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Baden-Baden, Bad-wur, Tyskland, 76532
- Praxis Dr. med. Irtel von Brenndorff
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Gaggenau, Bad-wur, Tyskland, 76571
- Praxis Dr. Med. Markert
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Heidelberg, Bad-wur, Tyskland, 69123
- Praxis Dr. med. Behroz
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N. Rhin
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Dortmund, N. Rhin, Tyskland, 44137
- Praxis Dr. med. Thomas Fadgyas
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Saxony
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Annaberg-Buchholz, Saxony, Tyskland, 9456
- Praxis Dr. med. Bernhardt
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Chemnitz, Saxony, Tyskland, 09126
- Praxis Dr. Med. Stellmach
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Nossen, Saxony, Tyskland, 01683
- Praxis Frau Dr. med. Strucks
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Pirna, Saxony, Tyskland, 1796
- Klinikum Pirna GmbH Klinik für Innere Medizin II
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Sxnyanh
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Oschersleben, Sxnyanh, Tyskland, 39387
- Kreiskrankenhaus des Bördekreises Krankenhaus 4
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Thurgia
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Erfurt, Thurgia, Tyskland, 99084
- Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang
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Erfurt, Thurgia, Tyskland, 99089
- Helios-Klinikum Erfurt GmbH
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients implanted with market released SJM Optim lead and a compatible market released CRM implantable pulse generator (pacemaker, implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy device (CRT)) is eligible for enrollment into the registry.
Beskrivelse
Inclusion Criteria:
- Patient has a standard indication for a CRM implantable pulse generator.
- Patient receives a market released SJM Optim lead at implant.
- Patient receives a market released CRM implantable pulse generator at implant.
- Patient is willing to provide authorization for registry participation.
- Complete device implant information, including any Optim lead related adverse event is available
Exclusion Criteria:
- Patient has medical conditions or related factors that would prevent or limit participation (including mechanical tricuspid valves, tricuspid valvular disease, and candidacy for heart transplants within 6 months).
- Patient is < 18 years of age.
- Patient has a life expectancy of < 2 years (malignancies)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Optim Leads
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Survival from insulation related adverse events
Tidsramme: 5 years
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5 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Grant Kim, Abbott Medical Devices
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)
1. august 2006
Primær færdiggørelse (Faktiske)
1. juli 2020
Studieafslutning (Faktiske)
1. juli 2020
Datoer for studieregistrering
Først indsendt
2. november 2012
Først indsendt, der opfyldte QC-kriterier
2. november 2012
Først opslået (Skøn)
6. november 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. maj 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. maj 2021
Sidst verificeret
1. maj 2021
Mere information
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 .