Lead Registry for Optim Leads (OPTIMUM)
7 maggio 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
14124
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Liège, Belgio, 4000
- CHR Citadelle
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Hamberg, Germania, 20099
- Asklepios Klinik St. Georg
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Hamberg, Germania, 22417
- Asklepios Klinik Nord Heidberg-Ochsenzoll
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Hamberg, Germania, 22763
- Asklepios Klinik Altona
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Hamburg, Germania, 20095
- Praxis Dr. med. Subin
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Bad-wur
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Baden-Baden, Bad-wur, Germania, 76532
- Praxis Dr. med. Irtel von Brenndorff
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Gaggenau, Bad-wur, Germania, 76571
- Praxis Dr. Med. Markert
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Heidelberg, Bad-wur, Germania, 69123
- Praxis Dr. med. Behroz
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N. Rhin
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Dortmund, N. Rhin, Germania, 44137
- Praxis Dr. med. Thomas Fadgyas
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Saxony
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Annaberg-Buchholz, Saxony, Germania, 9456
- Praxis Dr. med. Bernhardt
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Chemnitz, Saxony, Germania, 09126
- Praxis Dr. Med. Stellmach
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Nossen, Saxony, Germania, 01683
- Praxis Frau Dr. med. Strucks
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Pirna, Saxony, Germania, 1796
- Klinikum Pirna GmbH Klinik für Innere Medizin II
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Sxnyanh
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Oschersleben, Sxnyanh, Germania, 39387
- Kreiskrankenhaus des Bördekreises Krankenhaus 4
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Thurgia
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Erfurt, Thurgia, Germania, 99084
- Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang
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Erfurt, Thurgia, Germania, 99089
- Helios-Klinikum Erfurt GmbH
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Alabama
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Alabaster, Alabama, Stati Uniti, 35007
- Heart South Cardiovascular Group PC
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Fort Payne, Alabama, Stati Uniti, 35968
- Appalachian Cardiovascular Associates
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Gadsden, Alabama, Stati Uniti, 35903
- North Alabama Cardiology Center
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Mobile, Alabama, Stati Uniti, 36608
- Cardiology Associates of Mobile, Inc.
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Alaska
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Anchorage, Alaska, Stati Uniti, 99508
- Alaska Heart Institute
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Arizona
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Tucson, Arizona, Stati Uniti, 85723
- Southern Arizona VA Health Care System
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Tucson, Arizona, Stati Uniti, 85712
- Pima Heart Physicians, PC
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72205
- Arkansas Cardiology
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Little Rock, Arkansas, Stati Uniti, 72211
- *Little Rock Cardiology Clinic
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Springdale, Arkansas, Stati Uniti, 72764
- Northwest Cardiology
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California
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Beverly Hills, California, Stati Uniti, 90211
- Westside Cardiovascular Associates
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Burbank, California, Stati Uniti, 91505
- Raymond Schaerf, MD
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Burlingame, California, Stati Uniti, 94010
- Mills-Peninsula Cardiovascular Specialists
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Encino, California, Stati Uniti, 91436
- Center for Interventional Cardiology and Nephrology
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Fresno, California, Stati Uniti, 93650
- Cardiac Institute
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Fresno, California, Stati Uniti, 93720
- Mid Valley Cardiology
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Glendale, California, Stati Uniti, 91204
- Glendale Memorial Hospital and Medical Center
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Glendale, California, Stati Uniti, 91203
- Cardiac Care Specialists
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Inglewood, California, Stati Uniti, 90301
- Apex Cardiology
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Lakewood, California, Stati Uniti, 90712
- Kartik Thaker, MD Inc.
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Los Alamitos, California, Stati Uniti, 90720
- Omid Vahdat M.D.
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Los Angeles, California, Stati Uniti, 90048
- Jeffrey Goodman MD
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Los Angeles, California, Stati Uniti, 90048
- Donna Gallik MD
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Los Angeles, California, Stati Uniti, 90067
- Payam Yashar M.D.
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Mission Viejo, California, Stati Uniti, 92691
- Stephen S. Ehrlich, MD
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Murrieta, California, Stati Uniti, 95263
- Inland Valley Cardiovascular Center
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Northridge, California, Stati Uniti, 91325
- Mehrdad Ariani MD
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Northridge, California, Stati Uniti, 91325
- Soltera Yasuda & Associates
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Oxnard, California, Stati Uniti, 93030
- Cabrillo Cardiology Medical Group
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Oxnard, California, Stati Uniti, 93036
- Alejandro Garcia MD
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Palm Springs, California, Stati Uniti, 92262
- Desert Heart Physicians
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Pasadena, California, Stati Uniti, 91105
- Southern California Heart Specialists
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Rancho Mirage, California, Stati Uniti, 92270
- William A Stellar, MD
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Reseda, California, Stati Uniti, 91335
- Cardiac Rhythm Specialists, Inc.
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Riverside, California, Stati Uniti, 34232
- Heart Center of Riverside
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Sacramento, California, Stati Uniti, 95816
- Mercy Medical Group Cardiology
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Salinas, California, Stati Uniti, 93901
- Salinas Valley Memorial Hospital
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Santa Maria, California, Stati Uniti, 93454
- Bruce A. Ourieff MD
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Sun City, California, Stati Uniti, 92586
- Sun City Cardiology Medical Center, Incorporated
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Sun City, California, Stati Uniti, 92586
- Sun City Cardiology Medical Center, Inc
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Tarzana, California, Stati Uniti, 91356
- Michael Burnam, MD
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Tarzana, California, Stati Uniti, 91356
- Richard P. Cain, MD
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Torrance, California, Stati Uniti, 90505
- COR Healthcare Medical Associates
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Van Nuys, California, Stati Uniti, 91405
- Cardiovascular Consultants
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Van Nuys, California, Stati Uniti, 91406
- Arash Vahdat, MD
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Wildomar, California, Stati Uniti, 92595
- Shiva Heart Center Medical Group
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Yuba City, California, Stati Uniti, 95991
- Feather River Cardiovascular Institute
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Yuba City, California, Stati Uniti, 95991
- Yuba Sutter Medical Clinic
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Colorado
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Colorado Springs, Colorado, Stati Uniti, 80909
- Pikes Peak Cardiology
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Colorado Springs, Colorado, Stati Uniti, 80907
- Penrose St. Francis Cardiology Associates PC
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Denver, Colorado, Stati Uniti, 80210
- Harvard Park Medical
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Littleton, Colorado, Stati Uniti, 80120
- South Denver Cardiology Associates PC
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Connecticut
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New Britain, Connecticut, Stati Uniti, 06052
- Grove Hill Medical Center
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Norwalk, Connecticut, Stati Uniti, 06851
- Cardiology Associates of Fairfield County, PC
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Florida
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Boca Raton, Florida, Stati Uniti, 33422
- Cardiac Arrhythmia Services
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Bradenton, Florida, Stati Uniti, 34209
- Bradenton Heart Center
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Brandon, Florida, Stati Uniti, 33511
- Bay Area Cardiology Associates PA
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Brooksville, Florida, Stati Uniti, 34613
- Florida Cardiology Group
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Clearwater, Florida, Stati Uniti, 33756
- Pinellas Arrhythmia Associates
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Crestview, Florida, Stati Uniti, 32539
- Okaloosa Heart and Vascular
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Daytona Beach, Florida, Stati Uniti, 32114
- Cardiology Consultants PA
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Delray Beach, Florida, Stati Uniti, 33484
- The Cardiology Center, Incorporated
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Fort Walton Beach, Florida, Stati Uniti, 32547
- White-Wilson Medical Center - Fort Walton Beach
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Gainesville, Florida, Stati Uniti, 32610
- Shands at the University of Florida
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Gainesville, Florida, Stati Uniti, 32605
- The Cardiac & Vascular Institute Research Foundation, LLC
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Hollywood, Florida, Stati Uniti, 33021
- Florida Institute for Cardiovascular Care
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Lake Mary, Florida, Stati Uniti, 32746
- Jorge Diaz, M.D., P.A.
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Lakeland, Florida, Stati Uniti, 33806-2098
- Clark & Daughtrey Medical Group, PA
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Melbourne, Florida, Stati Uniti, 32901
- Melbourne Internal Medicine Associates
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Melbourne, Florida, Stati Uniti, 32901
- Diagnostic and Interventional Cardiology
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Miami Beach, Florida, Stati Uniti, 33140
- Miami International Cardiology Consultants Inc
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Ocala, Florida, Stati Uniti, 34474
- Central Florida Heart Center
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Ocala, Florida, Stati Uniti, 34471
- Institute of Cardiovascular Research LLC
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Ocala, Florida, Stati Uniti, 34471
- Ram Vasudevan, MD, FACC
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Orlando, Florida, Stati Uniti, 32803
- Cardiovascular Interventions, P.A.
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Orlando, Florida, Stati Uniti, 32806
- Mid-Florida Cardiology Specialist
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Ormond Beach, Florida, Stati Uniti, 32174
- Cardiology Research Associates
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Palatka, Florida, Stati Uniti, 32177
- Cardio Care Center
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Saint Augustine, Florida, Stati Uniti, 32086
- St. Augustine Cardiology Associates
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Sarasota, Florida, Stati Uniti, 34232
- Heart Care Research
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Sarasota, Florida, Stati Uniti, 34239
- Sarasota Heart Center
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Sarasota, Florida, Stati Uniti, 34321
- Sarasota Arrhythmia Institute
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Summerfield, Florida, Stati Uniti, 34491
- Dr. Kalpesh Solanki
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Tallahassee, Florida, Stati Uniti, 32308
- Tallahassee Research Institute
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Tamarac, Florida, Stati Uniti, 33321
- Mazhar Majid, M.D.
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Venice, Florida, Stati Uniti, 34292
- Heart & Vascular Center of Venice
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Georgia
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Athens, Georgia, Stati Uniti, 30606
- Piedmont Athens Regional Medical Center
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Athens, Georgia, Stati Uniti, 30606
- Athens Heart Center
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Athens, Georgia, Stati Uniti, 30606
- St. Mary's
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Atlanta, Georgia, Stati Uniti, 30309
- Piedmont Heart Institute - Buckhead Location
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Gainesville, Georgia, Stati Uniti, 30501
- Northeast Georgia Heart Foundation
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Lawrenceville, Georgia, Stati Uniti, 30045
- Gwinnet Consultants in Cardiology
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Marietta, Georgia, Stati Uniti, 30060
- Kennestone Heart Physicians
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Rome, Georgia, Stati Uniti, 30165
- Harbin Clinic Southeastern Cardiovascular Institute
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Valdosta, Georgia, Stati Uniti, 31602
- South Georgia Cardiology PC
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Illinois
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Aurora, Illinois, Stati Uniti, 60504
- Fox Valley Cardiovascular Consultants
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Elgin, Illinois, Stati Uniti, 60123
- Provena Saint Joseph Hospital
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Oak Lawn, Illinois, Stati Uniti, 60453
- MidAmerica Cardiovascular Consultants
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Rockford, Illinois, Stati Uniti, 61107
- Rockford Cardiology Associates
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Indiana
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Evansville, Indiana, Stati Uniti, 47714
- Ohio Valley Heart Care
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Hammond, Indiana, Stati Uniti, 46320
- Saint Margaret Mercy Healthcare Centers
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Jeffersonville, Indiana, Stati Uniti, 47130
- River Cities Cardiology
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Muncie, Indiana, Stati Uniti, 47303
- Medical Consultants
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Munster, Indiana, Stati Uniti, 46321
- Cardiology Associates of NW Indiana
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Iowa
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Des Moines, Iowa, Stati Uniti, 50316
- Unitypoint
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Kentucky
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Ashland, Kentucky, Stati Uniti, 41101
- Cumberland Cardiology
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Lexington, Kentucky, Stati Uniti, 40504
- Cardiology Associates of Kentucky
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Louisville, Kentucky, Stati Uniti, 40215
- Bluegrass Cardiology
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Madisonville, Kentucky, Stati Uniti, 42431
- Baptist Health Medical Group, Inc.
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Louisiana
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Alexandria, Louisiana, Stati Uniti, 71301
- Alexandria Cardiology Clinic
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Alexandria, Louisiana, Stati Uniti, 71301
- Freedman Memorial Cardiology
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Baton Rouge, Louisiana, Stati Uniti, 70808
- Our Lady of the Lake Hospital
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Covington, Louisiana, Stati Uniti, 70433
- Cardiovascular Associates
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Covington, Louisiana, Stati Uniti, 70433
- Covington Cardiovascular Care
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Covington, Louisiana, Stati Uniti, 70433
- St. Tammany Heart and Vascular
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Lacombe, Louisiana, Stati Uniti, 70445
- Heart and Vascular Institute of LA LLC
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Lafayette, Louisiana, Stati Uniti, 70503
- Mike Mounir MD
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Lake Charles, Louisiana, Stati Uniti, 70601
- Imperial Health, LLP
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Lake Charles, Louisiana, Stati Uniti, 70601
- Cardiovascular Specialists of SWLA
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Marrero, Louisiana, Stati Uniti, 70072
- Cardiology Center
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Monroe, Louisiana, Stati Uniti, 71201
- Gregory C. Sampognaro Interventional Cardiology
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Shreveport, Louisiana, Stati Uniti, 71105
- Cardiology Associates Incorporated
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Maine
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Bangor, Maine, Stati Uniti, 04401
- Eastern Maine Medical Center
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Maryland
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Bethesda, Maryland, Stati Uniti, 20889
- National Naval Medical Center
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Rockville, Maryland, Stati Uniti, 20850
- Cardiac Associates PC
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Salisbury, Maryland, Stati Uniti, 21804
- Peninsula Cardiology Associates, P.A.
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Salisbury, Maryland, Stati Uniti, 21804
- Delmarva Heart
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Silver Spring, Maryland, Stati Uniti, 20902
- Alan Schneider
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Massachusetts
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Florence, Massachusetts, Stati Uniti, 01062
- Baystate Medical Practice
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Hyannis, Massachusetts, Stati Uniti, 02601
- The Cardiovascular Specialists
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Worcester, Massachusetts, Stati Uniti, 01655
- University of Massachusetts Medical Center
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Worcester, Massachusetts, Stati Uniti, 01608
- Fallon Clinic
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Worcester, Massachusetts, Stati Uniti, 01608
- Heart Rhythm Specialists of Central Massachusetts, PC
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Michigan
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Birmingham, Michigan, Stati Uniti, 48009
- Cardiology and Arrhythmia Consultants P.C.
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Grand Blanc, Michigan, Stati Uniti, 48439
- Regional Cardiology Associates, PLC
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Rochester Hills, Michigan, Stati Uniti, 48307
- Academic Cardiology Associates
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Southfield, Michigan, Stati Uniti, 48075
- Heart Cardiology Consultants
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Traverse City, Michigan, Stati Uniti, 49684
- Grand Traverse Heart Associates
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Warren, Michigan, Stati Uniti, 48093
- Lingareddy Devireddy, PC
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Minnesota
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Duluth, Minnesota, Stati Uniti, 55802
- St. Luke's Cardiology Associates
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Minneapolis, Minnesota, Stati Uniti, 55417
- VA Medical Center Minneapolis
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Minneapolis, Minnesota, Stati Uniti, 55455
- University of Minnesota Medical Center Fairview
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Mississippi
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Biloxi, Mississippi, Stati Uniti, 39532
- Coast Cardiovascular Consultants
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Gulfport, Mississippi, Stati Uniti, 39503
- Coast Cardiology Center
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Hattiesburg, Mississippi, Stati Uniti, 39401
- Hattiesburg Clinic
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Missouri
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Cape Girardeau, Missouri, Stati Uniti, 63703
- Cardiovascular Consultants of Cape Girardeau Inc
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Florissant, Missouri, Stati Uniti, 63031
- The Heart Care Group
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Kansas City, Missouri, Stati Uniti, 64111
- Cardiovascular Consultants (now St. Luke's)
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Saint Louis, Missouri, Stati Uniti, 63110
- St. Louis University Hospital
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Saint Louis, Missouri, Stati Uniti, 63128
- County Cardiology, Inc.
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Saint Louis, Missouri, Stati Uniti, 63141-6835
- The Heart Health Center
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Saint Louis, Missouri, Stati Uniti, 63146
- St. Louis Cardiology Consultants
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68198
- University of Nebraska Medical Center
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Omaha, Nebraska, Stati Uniti, 68114
- Methodist Physicians Clinic-Heart Consultants
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Omaha, Nebraska, Stati Uniti, 68124
- Alegent Creighton Health
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89109
- Nevada Cardiology Associates
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New Jersey
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Camden, New Jersey, Stati Uniti, 08103
- Cooper University Hospital
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Cherry Hill, New Jersey, Stati Uniti, 08002
- South Jersey Heart Group
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Flemington, New Jersey, Stati Uniti, 08822
- Hunterdon Cardiovascular Associates
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Hamilton, New Jersey, Stati Uniti, 08690
- Hamilton Cardiology Associates
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Morristown, New Jersey, Stati Uniti, 07962
- Atlantic Health System - Morristown Memorial Hospital
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Ocean City, New Jersey, Stati Uniti, 07712
- Monmouth Cardiology Associates, LLC
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Wayne, New Jersey, Stati Uniti, 07470
- Cardiology Consultants of North Jersey
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West Orange, New Jersey, Stati Uniti, 07052
- New Jersey Cardiology Associates
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87102
- New Mexico Heart Institute
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New York
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Glens Falls, New York, Stati Uniti, 12801
- Adirondack Cardiology Associates
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Mineola, New York, Stati Uniti, 11501
- Long Island Heart Associates
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Roslyn, New York, Stati Uniti, 11576
- Cardiac Arrhythmia and Pacemaker Center
-
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North Carolina
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Goldsboro, North Carolina, Stati Uniti, 27534
- Wayne Heart Internal Medicine
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Hickory, North Carolina, Stati Uniti, 28602
- Piedmont Cardiology Associates
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Raleigh, North Carolina, Stati Uniti, 27610
- Wake Heart Associates
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North Dakota
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Fargo, North Dakota, Stati Uniti, 58112
- Sanford Research
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Grand Forks, North Dakota, Stati Uniti, 58201
- Altru Clinic - Main
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Ohio
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Barberton, Ohio, Stati Uniti, 44203
- City Cardiology Associates
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Columbus, Ohio, Stati Uniti, 43222
- Electrophysiology & Pacing Interventionalists
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Columbus, Ohio, Stati Uniti, 43222
- Electrophysiology and Pacing Interventionalists
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Elyria, Ohio, Stati Uniti, 44035
- University Hospitals Elyria Medical Center
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Fairfield, Ohio, Stati Uniti, 45014
- Mercy Hospital Fairfield
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Springfield, Ohio, Stati Uniti, 45504
- Ohio Institute Of Cardiac Care
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Steubenville, Ohio, Stati Uniti, 43952
- Heart Care Cardiology Consultants, Inc.
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Steubenville, Ohio, Stati Uniti, 43952
- Riverside Medical of Ohio
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Toledo, Ohio, Stati Uniti, 43623
- Toledo Clinic
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Toledo, Ohio, Stati Uniti, 43615
- Northwest Ohio Cardiology Consultants
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Youngstown, Ohio, Stati Uniti, 44504
- Ohio Heart Institute
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Youngstown, Ohio, Stati Uniti, 44505
- Cardiac Arrhythmia Associates
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73112
- Khastgir, Terrance M.D.
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Tulsa, Oklahoma, Stati Uniti, 74136
- Cardiovascular Consultants, Inc.
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Pennsylvania
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Abington, Pennsylvania, Stati Uniti, 19001
- Abington Medical Specialists
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Butler, Pennsylvania, Stati Uniti, 16001
- SouthWestern Pennsylvania Cardiovascular Associates
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Hospital of the University of Pennsylvania
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Sandy, Pennsylvania, Stati Uniti, 15801
- Dubois Regional Cardiology Associates
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Sayre, Pennsylvania, Stati Uniti, 18840
- Donald Guthrie Foundation for Education and Research
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29425
- Medical University of South Carolina
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Charleston, South Carolina, Stati Uniti, 29403
- Charleston Cardiology
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Charleston, South Carolina, Stati Uniti, 29407
- Coastal Cardiology
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Columbia, South Carolina, Stati Uniti, 29204
- South Carolina Heart Center
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Florence, South Carolina, Stati Uniti, 29506
- Pee Dee Cardiology Associates, PA
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Greenwood, South Carolina, Stati Uniti, 29646
- Piedmont Cardiology
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Tennessee
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Chattanooga, Tennessee, Stati Uniti, 37404
- The Chattanooga Heart Institute
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Johnson City, Tennessee, Stati Uniti, 37601
- Mountain States Medical Group Cardiology
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Knoxville, Tennessee, Stati Uniti, 37922
- Knoxville Cardiovascular Research Group, LLC
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Knoxville, Tennessee, Stati Uniti, 37920
- East Tennessee Heart Consultants - Knoxville
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Memphis, Tennessee, Stati Uniti, 38104
- Arrhythmia Consultants, P.C.
-
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Texas
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Austin, Texas, Stati Uniti, 78705
- Heart Rhythm Consultants
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Bay City, Texas, Stati Uniti, 77404
- Bay City Cardiology Clinic at Matagorda General Hospital
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Beaumont, Texas, Stati Uniti, 77702
- Southeast Texas Cardiology
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College Station, Texas, Stati Uniti, 77845
- BCS Heart, LLP
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Dallas, Texas, Stati Uniti, 75390-9016
- University of Texas Southwestern Medical Center at Dallas
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Dallas, Texas, Stati Uniti, 75230
- Dallas Heart Group
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Dallas, Texas, Stati Uniti, 75231-3833
- North Texas Heart Center
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El Paso, Texas, Stati Uniti, 79936
- Cardiology Care Consultants
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Fort Worth, Texas, Stati Uniti, 76104
- Texas Heart Clinic, PA
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Houston, Texas, Stati Uniti, 77030
- Willowbrook Cardiovascular Associates
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Houston, Texas, Stati Uniti, 77030
- Center for Cardiac Arrhythmias
-
Houston, Texas, Stati Uniti, 77030
- EP/Cardiology PA
-
Humble, Texas, Stati Uniti, 77338
- Cardiovascular Association, P.L.L.C.
-
Lubbock, Texas, Stati Uniti, 79410
- Texas Cardiac Center
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Midland, Texas, Stati Uniti, 79761
- Permian Cardiology Associates
-
Odessa, Texas, Stati Uniti, 79761
- Odessa Heart Institute, P. A.
-
Orange, Texas, Stati Uniti, 77630
- Miguel E. Castellanos, MD
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San Antonio, Texas, Stati Uniti, 78201
- South Texas Cardiovascular Consultants
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San Antonio, Texas, Stati Uniti, 78229
- Cardiology Clinic Of San Antonio Pa
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San Antonio, Texas, Stati Uniti, 78234
- Brooke Army Medical Center, Division of Cardiology
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Temple, Texas, Stati Uniti, 76508
- Scott & White Memorial Hospital
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Tyler, Texas, Stati Uniti, 75701
- Cardiovascular Associates of East Texas
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Victoria, Texas, Stati Uniti, 77901
- Victoria Heart and Vascular
-
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Virginia
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Chesapeake, Virginia, Stati Uniti, 23320
- Cardiovascular Associates Ltd
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Fairfax, Virginia, Stati Uniti, 22031
- The Cardiovascular Group
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Falls Church, Virginia, Stati Uniti, 22042
- Inova Fairfax Hospital
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Hampton, Virginia, Stati Uniti, 23666
- Riverside Heart Specialists
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Harrisonburg, Virginia, Stati Uniti, 22801
- Harrisonburg Medical Associations, Inc.
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Richmond, Virginia, Stati Uniti, 23229
- Virginia Cardiovascular Specialists
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Richmond, Virginia, Stati Uniti, 23249
- Hunter Holmes McGuire VAMC
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Washington
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Bellevue, Washington, Stati Uniti, 98004
- Overlake Internal Medicine Associates
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Bellevue, Washington, Stati Uniti, 98004
- Bellevue Cardiology
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Bremerton, Washington, Stati Uniti, 98310
- Kitsap Cardiology Consultants
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Mount Vernon, Washington, Stati Uniti, 98274
- Skagit Valley Medical Center
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Seattle, Washington, Stati Uniti, 98111
- The Heart Institute at Virginia Mason
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Spokane, Washington, Stati Uniti, 99202
- Sacred Heart Medical Center
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Spokane, Washington, Stati Uniti, 99204
- Kootenai Heart Clinics
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Tacoma, Washington, Stati Uniti, 98405
- Franciscan Heart & Vascular Associates
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Tacoma, Washington, Stati Uniti, 98405
- Franciscan Cardiology Associates
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Wisconsin
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Green Bay, Wisconsin, Stati Uniti, 54301-3528
- Cardiology Associates of Green Bay, Ltd.
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Madison, Wisconsin, Stati Uniti, 53792
- University of Wisconsin Hospital and Clinics
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Madison, Wisconsin, Stati Uniti, 53715
- Dean Foundation
-
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
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.
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
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Optim Leads
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Survival from insulation related adverse events
Lasso di tempo: 5 years
|
5 years
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Grant Kim, Abbott Medical Devices
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 agosto 2006
Completamento primario (Effettivo)
1 luglio 2020
Completamento dello studio (Effettivo)
1 luglio 2020
Date di iscrizione allo studio
Primo inviato
2 novembre 2012
Primo inviato che soddisfa i criteri di controllo qualità
2 novembre 2012
Primo Inserito (Stima)
6 novembre 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 maggio 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 maggio 2021
Ultimo verificato
1 maggio 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- CD0196
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .