Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
1735 participants
OBSERVATIONAL
2014-08-31
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead
St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead
Interventions
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St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead
Eligibility Criteria
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Inclusion Criteria
1. Have an approved indication, as per ACC/AHA/HRS/ESC guidelines, for implantation of an ICD or CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
2. Have been implanted with a St. Jude Medical Optisure lead in the last 30 days or are scheduled for an Optisure lead implant.
3. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
4. Are 18 years or above, or of legal age to give informed consent specific to state and national law.
Exclusion Criteria
1. Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study.
2. Have a life expectancy of less than 5 years due to any condition.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Nicole Harbert
Role: STUDY_DIRECTOR
Abbott
Locations
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Baptist Medical Center Princeton
Birmingham, Alabama, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
St. Bernards (formerly Cardiology Associates of Northeast Arkansas)
Jonesboro, Arkansas, United States
Raymond Schaerf, MD
Burbank, California, United States
Desert Heart Rhythm Consultants
Palm Springs, California, United States
Cardiac Rhythm Specialists, Inc.
Reseda, California, United States
San Diego Heart Rhythm Center (formerly San Diego Heart and Vascular Associates)
San Diego, California, United States
Jorge Diaz, M.D. , P.A.
Lake Mary, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Rockford Cardiology Associates
Rockford, Illinois, United States
Parkview Research Center
Fort Wayne, Indiana, United States
Iowa Heart Center
West Des Moines, Iowa, United States
St. Elizabeth Medical Center - South Unit
Edgewood, Kentucky, United States
Peninsula Cardiology Associates
Salisbury, Maryland, United States
Mass Heart & Rhythm
Leominster, Massachusetts, United States
Premier Medical Clinics
Flint, Michigan, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Northern Michigan Hospital
Traverse City, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, United States
HealthCare Partners Cardiology
Las Vegas, Nevada, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, United States
Lourdes Cardiology Services
Voorhees Township, New Jersey, United States
Presbyterian Heart Group
Albuquerque, New Mexico, United States
Maimonides Medical Center
Brooklyn, New York, United States
Coney Island Hospital
Brooklyn, New York, United States
Cardiovascular Group of Syracuse
Liverpool, New York, United States
High Point Regional Health (formerly Carolina Cardiology Cornerstone)
High Point, North Carolina, United States
CarolinaEast Heart Center
New Bern, North Carolina, United States
VA Medical Center Cleveland
Cleveland, Ohio, United States
Great Lakes Medical Research, LLC
Willoughby, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Providence Heart and Vascular Institute
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Arrhythmia Institute
Newtown, Pennsylvania, United States
The Stern Cardiovascular Foundation
Germantown, Tennessee, United States
HeartPlace
Bedford, Texas, United States
VA Medical Center Dallas
Dallas, Texas, United States
Cardiology Care Consultants
El Paso, Texas, United States
Scott & White Memorial Hospital
Temple, Texas, United States
Heart of Dixie Cardiology (formerly Dixie Regional Medical Center - River Road Campus)
St. George, Utah, United States
Mary Washington Hospital
Fredericksburg, Virginia, United States
Virginia Cardiovascular Specialists
Richmond, Virginia, United States
Aurora Medical Group
Milwaukee, Wisconsin, United States
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
Royal Alexandra Hospital
Edmonton, Alberta, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
QE II Health Sciences
Halifax, Nova Scotia, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Rouge Valley Centenary
Scarborough Village, Ontario, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, Canada
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, , Germany
Tokyo Women's Medical University
Shinjuku-Ku, Kanto, Japan
Osaka City University Hospital
Abeno-ku, Osaka, Japan
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, Japan
Mc-Tronik
Lodz, , Poland
Santa Maria Hospital
Lisbon, Lisbon District, Portugal
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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60045220
Identifier Type: -
Identifier Source: org_study_id
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