Lead Registry for Optim Leads (OPTIMUM)
7. mai 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
14124
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Liège, Belgia, 4000
- CHR Citadelle
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Alabama
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Alabaster, Alabama, Forente stater, 35007
- Heart South Cardiovascular Group PC
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Fort Payne, Alabama, Forente stater, 35968
- Appalachian Cardiovascular Associates
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Gadsden, Alabama, Forente stater, 35903
- North Alabama Cardiology Center
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Mobile, Alabama, Forente stater, 36608
- Cardiology Associates of Mobile, Inc.
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Alaska
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Anchorage, Alaska, Forente stater, 99508
- Alaska Heart Institute
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Arizona
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Tucson, Arizona, Forente stater, 85723
- Southern Arizona VA Health Care System
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Tucson, Arizona, Forente stater, 85712
- Pima Heart Physicians, PC
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Arkansas
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Little Rock, Arkansas, Forente stater, 72205
- Arkansas Cardiology
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Little Rock, Arkansas, Forente stater, 72211
- *Little Rock Cardiology Clinic
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Springdale, Arkansas, Forente stater, 72764
- Northwest Cardiology
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California
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Beverly Hills, California, Forente stater, 90211
- Westside Cardiovascular Associates
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Burbank, California, Forente stater, 91505
- Raymond Schaerf, MD
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Burlingame, California, Forente stater, 94010
- Mills-Peninsula Cardiovascular Specialists
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Encino, California, Forente stater, 91436
- Center for Interventional Cardiology and Nephrology
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Fresno, California, Forente stater, 93650
- Cardiac Institute
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Fresno, California, Forente stater, 93720
- Mid Valley Cardiology
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Glendale, California, Forente stater, 91204
- Glendale Memorial Hospital and Medical Center
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Glendale, California, Forente stater, 91203
- Cardiac Care Specialists
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Inglewood, California, Forente stater, 90301
- Apex Cardiology
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Lakewood, California, Forente stater, 90712
- Kartik Thaker, MD Inc.
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Los Alamitos, California, Forente stater, 90720
- Omid Vahdat M.D.
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Los Angeles, California, Forente stater, 90048
- Jeffrey Goodman MD
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Los Angeles, California, Forente stater, 90048
- Donna Gallik MD
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Los Angeles, California, Forente stater, 90067
- Payam Yashar M.D.
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Mission Viejo, California, Forente stater, 92691
- Stephen S. Ehrlich, MD
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Murrieta, California, Forente stater, 95263
- Inland Valley Cardiovascular Center
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Northridge, California, Forente stater, 91325
- Mehrdad Ariani MD
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Northridge, California, Forente stater, 91325
- Soltera Yasuda & Associates
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Oxnard, California, Forente stater, 93030
- Cabrillo Cardiology Medical Group
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Oxnard, California, Forente stater, 93036
- Alejandro Garcia MD
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Palm Springs, California, Forente stater, 92262
- Desert Heart Physicians
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Pasadena, California, Forente stater, 91105
- Southern California Heart Specialists
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Rancho Mirage, California, Forente stater, 92270
- William A Stellar, MD
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Reseda, California, Forente stater, 91335
- Cardiac Rhythm Specialists, Inc.
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Riverside, California, Forente stater, 34232
- Heart Center of Riverside
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Sacramento, California, Forente stater, 95816
- Mercy Medical Group Cardiology
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Salinas, California, Forente stater, 93901
- Salinas Valley Memorial Hospital
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Santa Maria, California, Forente stater, 93454
- Bruce A. Ourieff MD
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Sun City, California, Forente stater, 92586
- Sun City Cardiology Medical Center, Incorporated
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Sun City, California, Forente stater, 92586
- Sun City Cardiology Medical Center, Inc
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Tarzana, California, Forente stater, 91356
- Michael Burnam, MD
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Tarzana, California, Forente stater, 91356
- Richard P. Cain, MD
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Torrance, California, Forente stater, 90505
- COR Healthcare Medical Associates
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Van Nuys, California, Forente stater, 91405
- Cardiovascular Consultants
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Van Nuys, California, Forente stater, 91406
- Arash Vahdat, MD
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Wildomar, California, Forente stater, 92595
- Shiva Heart Center Medical Group
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Yuba City, California, Forente stater, 95991
- Feather River Cardiovascular Institute
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Yuba City, California, Forente stater, 95991
- Yuba Sutter Medical Clinic
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Colorado
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Colorado Springs, Colorado, Forente stater, 80909
- Pikes Peak Cardiology
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Colorado Springs, Colorado, Forente stater, 80907
- Penrose St. Francis Cardiology Associates PC
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Denver, Colorado, Forente stater, 80210
- Harvard Park Medical
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Littleton, Colorado, Forente stater, 80120
- South Denver Cardiology Associates PC
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Connecticut
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New Britain, Connecticut, Forente stater, 06052
- Grove Hill Medical Center
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Norwalk, Connecticut, Forente stater, 06851
- Cardiology Associates of Fairfield County, PC
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Florida
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Boca Raton, Florida, Forente stater, 33422
- Cardiac Arrhythmia Services
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Bradenton, Florida, Forente stater, 34209
- Bradenton Heart Center
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Brandon, Florida, Forente stater, 33511
- Bay Area Cardiology Associates PA
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Brooksville, Florida, Forente stater, 34613
- Florida Cardiology Group
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Clearwater, Florida, Forente stater, 33756
- Pinellas Arrhythmia Associates
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Crestview, Florida, Forente stater, 32539
- Okaloosa Heart and Vascular
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Daytona Beach, Florida, Forente stater, 32114
- Cardiology Consultants PA
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Delray Beach, Florida, Forente stater, 33484
- The Cardiology Center, Incorporated
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Fort Walton Beach, Florida, Forente stater, 32547
- White-Wilson Medical Center - Fort Walton Beach
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Gainesville, Florida, Forente stater, 32610
- Shands at the University of Florida
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Gainesville, Florida, Forente stater, 32605
- The Cardiac & Vascular Institute Research Foundation, LLC
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Hollywood, Florida, Forente stater, 33021
- Florida Institute for Cardiovascular Care
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Lake Mary, Florida, Forente stater, 32746
- Jorge Diaz, M.D., P.A.
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Lakeland, Florida, Forente stater, 33806-2098
- Clark & Daughtrey Medical Group, PA
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Melbourne, Florida, Forente stater, 32901
- Melbourne Internal Medicine Associates
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Melbourne, Florida, Forente stater, 32901
- Diagnostic and Interventional Cardiology
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Miami Beach, Florida, Forente stater, 33140
- Miami International Cardiology Consultants Inc
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Ocala, Florida, Forente stater, 34474
- Central Florida Heart Center
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Ocala, Florida, Forente stater, 34471
- Institute of Cardiovascular Research LLC
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Ocala, Florida, Forente stater, 34471
- Ram Vasudevan, MD, FACC
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Orlando, Florida, Forente stater, 32803
- Cardiovascular Interventions, P.A.
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Orlando, Florida, Forente stater, 32806
- Mid-Florida Cardiology Specialist
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Ormond Beach, Florida, Forente stater, 32174
- Cardiology Research Associates
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Palatka, Florida, Forente stater, 32177
- Cardio Care Center
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Saint Augustine, Florida, Forente stater, 32086
- St. Augustine Cardiology Associates
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Sarasota, Florida, Forente stater, 34232
- Heart Care Research
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Sarasota, Florida, Forente stater, 34239
- Sarasota Heart Center
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Sarasota, Florida, Forente stater, 34321
- Sarasota Arrhythmia Institute
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Summerfield, Florida, Forente stater, 34491
- Dr. Kalpesh Solanki
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Tallahassee, Florida, Forente stater, 32308
- Tallahassee Research Institute
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Tamarac, Florida, Forente stater, 33321
- Mazhar Majid, M.D.
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Venice, Florida, Forente stater, 34292
- Heart & Vascular Center of Venice
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Georgia
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Athens, Georgia, Forente stater, 30606
- Piedmont Athens Regional Medical Center
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Athens, Georgia, Forente stater, 30606
- Athens Heart Center
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Athens, Georgia, Forente stater, 30606
- St. Mary's
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Atlanta, Georgia, Forente stater, 30309
- Piedmont Heart Institute - Buckhead Location
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Gainesville, Georgia, Forente stater, 30501
- Northeast Georgia Heart Foundation
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Lawrenceville, Georgia, Forente stater, 30045
- Gwinnet Consultants in Cardiology
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Marietta, Georgia, Forente stater, 30060
- Kennestone Heart Physicians
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Rome, Georgia, Forente stater, 30165
- Harbin Clinic Southeastern Cardiovascular Institute
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Valdosta, Georgia, Forente stater, 31602
- South Georgia Cardiology PC
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Illinois
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Aurora, Illinois, Forente stater, 60504
- Fox Valley Cardiovascular Consultants
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Elgin, Illinois, Forente stater, 60123
- Provena Saint Joseph Hospital
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Oak Lawn, Illinois, Forente stater, 60453
- MidAmerica Cardiovascular Consultants
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Rockford, Illinois, Forente stater, 61107
- Rockford Cardiology Associates
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Indiana
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Evansville, Indiana, Forente stater, 47714
- Ohio Valley Heart Care
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Hammond, Indiana, Forente stater, 46320
- Saint Margaret Mercy Healthcare Centers
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Jeffersonville, Indiana, Forente stater, 47130
- River Cities Cardiology
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Muncie, Indiana, Forente stater, 47303
- Medical Consultants
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Munster, Indiana, Forente stater, 46321
- Cardiology Associates of NW Indiana
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Iowa
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Des Moines, Iowa, Forente stater, 50316
- Unitypoint
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Kentucky
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Ashland, Kentucky, Forente stater, 41101
- Cumberland Cardiology
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Lexington, Kentucky, Forente stater, 40504
- Cardiology Associates of Kentucky
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Louisville, Kentucky, Forente stater, 40215
- Bluegrass Cardiology
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Madisonville, Kentucky, Forente stater, 42431
- Baptist Health Medical Group, Inc.
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Louisiana
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Alexandria, Louisiana, Forente stater, 71301
- Alexandria Cardiology Clinic
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Alexandria, Louisiana, Forente stater, 71301
- Freedman Memorial Cardiology
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Baton Rouge, Louisiana, Forente stater, 70808
- Our Lady of the Lake Hospital
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Covington, Louisiana, Forente stater, 70433
- Cardiovascular Associates
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Covington, Louisiana, Forente stater, 70433
- Covington Cardiovascular Care
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Covington, Louisiana, Forente stater, 70433
- St. Tammany Heart and Vascular
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Lacombe, Louisiana, Forente stater, 70445
- Heart and Vascular Institute of LA LLC
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Lafayette, Louisiana, Forente stater, 70503
- Mike Mounir MD
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Lake Charles, Louisiana, Forente stater, 70601
- Imperial Health, LLP
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Lake Charles, Louisiana, Forente stater, 70601
- Cardiovascular Specialists of SWLA
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Marrero, Louisiana, Forente stater, 70072
- Cardiology Center
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Monroe, Louisiana, Forente stater, 71201
- Gregory C. Sampognaro Interventional Cardiology
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Shreveport, Louisiana, Forente stater, 71105
- Cardiology Associates Incorporated
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Maine
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Bangor, Maine, Forente stater, 04401
- Eastern Maine Medical Center
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Maryland
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Bethesda, Maryland, Forente stater, 20889
- National Naval Medical Center
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Rockville, Maryland, Forente stater, 20850
- Cardiac Associates PC
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Salisbury, Maryland, Forente stater, 21804
- Peninsula Cardiology Associates, P.A.
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Salisbury, Maryland, Forente stater, 21804
- Delmarva Heart
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Silver Spring, Maryland, Forente stater, 20902
- Alan Schneider
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Massachusetts
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Florence, Massachusetts, Forente stater, 01062
- Baystate Medical Practice
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Hyannis, Massachusetts, Forente stater, 02601
- The Cardiovascular Specialists
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Worcester, Massachusetts, Forente stater, 01655
- University of Massachusetts Medical Center
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Worcester, Massachusetts, Forente stater, 01608
- Fallon Clinic
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Worcester, Massachusetts, Forente stater, 01608
- Heart Rhythm Specialists of Central Massachusetts, PC
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Michigan
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Birmingham, Michigan, Forente stater, 48009
- Cardiology and Arrhythmia Consultants P.C.
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Grand Blanc, Michigan, Forente stater, 48439
- Regional Cardiology Associates, PLC
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Rochester Hills, Michigan, Forente stater, 48307
- Academic Cardiology Associates
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Southfield, Michigan, Forente stater, 48075
- Heart Cardiology Consultants
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Traverse City, Michigan, Forente stater, 49684
- Grand Traverse Heart Associates
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Warren, Michigan, Forente stater, 48093
- Lingareddy Devireddy, PC
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Minnesota
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Duluth, Minnesota, Forente stater, 55802
- St. Luke's Cardiology Associates
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Minneapolis, Minnesota, Forente stater, 55417
- VA Medical Center Minneapolis
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Minneapolis, Minnesota, Forente stater, 55455
- University of Minnesota Medical Center Fairview
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Mississippi
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Biloxi, Mississippi, Forente stater, 39532
- Coast Cardiovascular Consultants
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Gulfport, Mississippi, Forente stater, 39503
- Coast Cardiology Center
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Hattiesburg, Mississippi, Forente stater, 39401
- Hattiesburg Clinic
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Missouri
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Cape Girardeau, Missouri, Forente stater, 63703
- Cardiovascular Consultants of Cape Girardeau Inc
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Florissant, Missouri, Forente stater, 63031
- The Heart Care Group
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Kansas City, Missouri, Forente stater, 64111
- Cardiovascular Consultants (now St. Luke's)
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Saint Louis, Missouri, Forente stater, 63110
- St. Louis University Hospital
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Saint Louis, Missouri, Forente stater, 63128
- County Cardiology, Inc.
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Saint Louis, Missouri, Forente stater, 63141-6835
- The Heart Health Center
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Saint Louis, Missouri, Forente stater, 63146
- St. Louis Cardiology Consultants
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Nebraska
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Omaha, Nebraska, Forente stater, 68198
- University of Nebraska Medical Center
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Omaha, Nebraska, Forente stater, 68114
- Methodist Physicians Clinic-Heart Consultants
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Omaha, Nebraska, Forente stater, 68124
- Alegent Creighton Health
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Nevada
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Las Vegas, Nevada, Forente stater, 89109
- Nevada Cardiology Associates
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New Jersey
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Camden, New Jersey, Forente stater, 08103
- Cooper University Hospital
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Cherry Hill, New Jersey, Forente stater, 08002
- South Jersey Heart Group
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Flemington, New Jersey, Forente stater, 08822
- Hunterdon Cardiovascular Associates
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Hamilton, New Jersey, Forente stater, 08690
- Hamilton Cardiology Associates
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Morristown, New Jersey, Forente stater, 07962
- Atlantic Health System - Morristown Memorial Hospital
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Ocean City, New Jersey, Forente stater, 07712
- Monmouth Cardiology Associates, LLC
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Wayne, New Jersey, Forente stater, 07470
- Cardiology Consultants of North Jersey
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West Orange, New Jersey, Forente stater, 07052
- New Jersey Cardiology Associates
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87102
- New Mexico Heart Institute
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New York
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Glens Falls, New York, Forente stater, 12801
- Adirondack Cardiology Associates
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Mineola, New York, Forente stater, 11501
- Long Island Heart Associates
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Roslyn, New York, Forente stater, 11576
- Cardiac Arrhythmia and Pacemaker Center
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North Carolina
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Goldsboro, North Carolina, Forente stater, 27534
- Wayne Heart Internal Medicine
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Hickory, North Carolina, Forente stater, 28602
- Piedmont Cardiology Associates
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Raleigh, North Carolina, Forente stater, 27610
- Wake Heart Associates
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North Dakota
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Fargo, North Dakota, Forente stater, 58112
- Sanford Research
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Grand Forks, North Dakota, Forente stater, 58201
- Altru Clinic - Main
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Ohio
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Barberton, Ohio, Forente stater, 44203
- City Cardiology Associates
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Columbus, Ohio, Forente stater, 43222
- Electrophysiology & Pacing Interventionalists
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Columbus, Ohio, Forente stater, 43222
- Electrophysiology and Pacing Interventionalists
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Elyria, Ohio, Forente stater, 44035
- University Hospitals Elyria Medical Center
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Fairfield, Ohio, Forente stater, 45014
- Mercy Hospital Fairfield
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Springfield, Ohio, Forente stater, 45504
- Ohio Institute Of Cardiac Care
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Steubenville, Ohio, Forente stater, 43952
- Heart Care Cardiology Consultants, Inc.
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Steubenville, Ohio, Forente stater, 43952
- Riverside Medical of Ohio
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Toledo, Ohio, Forente stater, 43623
- Toledo Clinic
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Toledo, Ohio, Forente stater, 43615
- Northwest Ohio Cardiology Consultants
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Youngstown, Ohio, Forente stater, 44504
- Ohio Heart Institute
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Youngstown, Ohio, Forente stater, 44505
- Cardiac Arrhythmia Associates
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73112
- Khastgir, Terrance M.D.
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Tulsa, Oklahoma, Forente stater, 74136
- Cardiovascular Consultants, Inc.
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Pennsylvania
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Abington, Pennsylvania, Forente stater, 19001
- Abington Medical Specialists
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Butler, Pennsylvania, Forente stater, 16001
- SouthWestern Pennsylvania Cardiovascular Associates
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Philadelphia, Pennsylvania, Forente stater, 19104
- Hospital of the University of Pennsylvania
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Sandy, Pennsylvania, Forente stater, 15801
- Dubois Regional Cardiology Associates
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Sayre, Pennsylvania, Forente stater, 18840
- Donald Guthrie Foundation for Education and Research
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
- Medical University of South Carolina
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Charleston, South Carolina, Forente stater, 29403
- Charleston Cardiology
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Charleston, South Carolina, Forente stater, 29407
- Coastal Cardiology
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Columbia, South Carolina, Forente stater, 29204
- South Carolina Heart Center
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Florence, South Carolina, Forente stater, 29506
- Pee Dee Cardiology Associates, PA
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Greenwood, South Carolina, Forente stater, 29646
- Piedmont Cardiology
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37404
- The Chattanooga Heart Institute
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Johnson City, Tennessee, Forente stater, 37601
- Mountain States Medical Group Cardiology
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Knoxville, Tennessee, Forente stater, 37922
- Knoxville Cardiovascular Research Group, LLC
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Knoxville, Tennessee, Forente stater, 37920
- East Tennessee Heart Consultants - Knoxville
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Memphis, Tennessee, Forente stater, 38104
- Arrhythmia Consultants, P.C.
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Texas
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Austin, Texas, Forente stater, 78705
- Heart Rhythm Consultants
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Bay City, Texas, Forente stater, 77404
- Bay City Cardiology Clinic at Matagorda General Hospital
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Beaumont, Texas, Forente stater, 77702
- Southeast Texas Cardiology
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College Station, Texas, Forente stater, 77845
- BCS Heart, LLP
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Dallas, Texas, Forente stater, 75390-9016
- University of Texas Southwestern Medical Center at Dallas
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Dallas, Texas, Forente stater, 75230
- Dallas Heart Group
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Dallas, Texas, Forente stater, 75231-3833
- North Texas Heart Center
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El Paso, Texas, Forente stater, 79936
- Cardiology Care Consultants
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Fort Worth, Texas, Forente stater, 76104
- Texas Heart Clinic, PA
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Houston, Texas, Forente stater, 77030
- Willowbrook Cardiovascular Associates
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Houston, Texas, Forente stater, 77030
- Center for Cardiac Arrhythmias
-
Houston, Texas, Forente stater, 77030
- EP/Cardiology PA
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Humble, Texas, Forente stater, 77338
- Cardiovascular Association, P.L.L.C.
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Lubbock, Texas, Forente stater, 79410
- Texas Cardiac Center
-
Midland, Texas, Forente stater, 79761
- Permian Cardiology Associates
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Odessa, Texas, Forente stater, 79761
- Odessa Heart Institute, P. A.
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Orange, Texas, Forente stater, 77630
- Miguel E. Castellanos, MD
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San Antonio, Texas, Forente stater, 78201
- South Texas Cardiovascular Consultants
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San Antonio, Texas, Forente stater, 78229
- Cardiology Clinic Of San Antonio Pa
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San Antonio, Texas, Forente stater, 78234
- Brooke Army Medical Center, Division of Cardiology
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Temple, Texas, Forente stater, 76508
- Scott & White Memorial Hospital
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Tyler, Texas, Forente stater, 75701
- Cardiovascular Associates of East Texas
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Victoria, Texas, Forente stater, 77901
- Victoria Heart and Vascular
-
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Virginia
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Chesapeake, Virginia, Forente stater, 23320
- Cardiovascular Associates Ltd
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Fairfax, Virginia, Forente stater, 22031
- The Cardiovascular Group
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Falls Church, Virginia, Forente stater, 22042
- INOVA Fairfax Hospital
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Hampton, Virginia, Forente stater, 23666
- Riverside Heart Specialists
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Harrisonburg, Virginia, Forente stater, 22801
- Harrisonburg Medical Associations, Inc.
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Richmond, Virginia, Forente stater, 23229
- Virginia Cardiovascular Specialists
-
Richmond, Virginia, Forente stater, 23249
- Hunter Holmes McGuire VAMC
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Washington
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Bellevue, Washington, Forente stater, 98004
- Overlake Internal Medicine Associates
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Bellevue, Washington, Forente stater, 98004
- Bellevue Cardiology
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Bremerton, Washington, Forente stater, 98310
- Kitsap Cardiology Consultants
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Mount Vernon, Washington, Forente stater, 98274
- Skagit Valley Medical Center
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Seattle, Washington, Forente stater, 98111
- The Heart Institute at Virginia Mason
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Spokane, Washington, Forente stater, 99202
- Sacred Heart Medical Center
-
Spokane, Washington, Forente stater, 99204
- Kootenai Heart Clinics
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Tacoma, Washington, Forente stater, 98405
- Franciscan Heart & Vascular Associates
-
Tacoma, Washington, Forente stater, 98405
- Franciscan Cardiology Associates
-
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Wisconsin
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Green Bay, Wisconsin, Forente stater, 54301-3528
- Cardiology Associates of Green Bay, Ltd.
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Madison, Wisconsin, Forente stater, 53792
- University of Wisconsin Hospital and Clinics
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Madison, Wisconsin, Forente stater, 53715
- Dean Foundation
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-
-
-
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Hamberg, Tyskland, 20099
- Asklepios Klinik St. Georg
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Hamberg, Tyskland, 22417
- Asklepios Klinik Nord Heidberg-Ochsenzoll
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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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Optim Leads
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Hva måler studien?
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Grant Kim, Abbott Medical Devices
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. august 2006
Primær fullføring (Faktiske)
1. juli 2020
Studiet fullført (Faktiske)
1. juli 2020
Datoer for studieregistrering
Først innsendt
2. november 2012
Først innsendt som oppfylte QC-kriteriene
2. november 2012
Først lagt ut (Anslag)
6. november 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. mai 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mai 2021
Sist bekreftet
1. mai 2021
Mer informasjon
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .