Study Results
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View full resultsBasic Information
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COMPLETED
NA
216 participants
INTERVENTIONAL
2014-04-30
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CRT-D
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
CRT-D
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
Interventions
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CRT-D
For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
Eligibility Criteria
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Inclusion Criteria
2. Subjects who have an implanted functional endocardial right ventricular defibrillation lead or who will receive a endocardial right ventricular defibrillation lead
3. Subjects who have an implanted functional bipolar or unipolar left ventricular lead or who will receive a bipolar or unipolar left ventricular lead
4. Subjects who are willing and capable of providing informed consent to undergo a device implant procedure, and to participate in all testing and follow-ups defined in this protocol
5. Subjects whose age is 18 or above, or of legal age to give informed consent specific to national law
Exclusion Criteria
2. Subjects with an unknown model/manufacturer, or implant date for the RA, RV or LV lead
3. Subjects for whom a RV defibrillation lead manufactured by St. Jude Medical or Biotronik is implanted, is planned to be implanted, or has been abandoned
4. Implanted with an active Medtronic Sprint Fidelis® lead models: 6930, 6931, 6948 or 6949
5. Subjects with an implanted or abandoned St. Jude Medical QuickSite® or QuickFlex® lead models: 1056T, 1058T, 1156T, 1158T
6. Subjects with a RV or LV lead revision or extraction within 30 days of enrollment
7. Subjects with an implanted lead that is planned to be extracted during the study implant procedure
8. Subjects with an active implanted RA or RV lead that is greater than 10 years old, unless the lead will be abandoned
9. Subjects with an active implanted LV lead that is greater than 8 years old, unless the lead will be abandoned
10. Subjects preexisting unipolar pacemaker that will not be explanted/abandoned
11. Subjects with a life expectancy less than 6 months
12. Subjects with a prosthetic mechanical tricuspid heart valve
13. Women of childbearing age who are pregnant or plan to become pregnant. NOTE: women of childbearing potential with an uncertain pregnancy status must have a negative pregnancy test within 7 days prior to enrollment. Pregnancy tests are required as part of standard routing clinical practice at all centers whenever female patients are exposed to x-ray radiation. Since this protocol does not require any exposure of the female patients to x-ray and x-ray exposure is part of the clinical procedure, it is the responsibility of the investigators to ensure that pregnant females will not be exposed to x-ray at any time
14. Subject enrolled in a concurrent study, except national/governmental registries that do not require a signed informed consent form, without the written approval from Boston Scientific
15. Subjects who are not geographically stable, to the extent that it would prevent attending the study follow-ups at the investigational center
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth Ellenbogen, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University Medical Center
Locations
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Glendale Adventist Medical Center
Glendale, California, United States
Danbury Hospital
Danbury, Connecticut, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Delray Medical Center
Atlantis, Florida, United States
St. Vincent's Medical Center
Jacksonville, Florida, United States
Baptist Medical Center
Jacksonville, Florida, United States
First Coast Cardiovascular
Jacksonville, Florida, United States
Orlando Regional Medical Center
Orlando, Florida, United States
University Community Hospital
Trinity, Florida, United States
Winter Haven Hospital
Winter Haven, Florida, United States
Carle Foundation Hospital
Urbana, Illinois, United States
IU Health LaPorte
La Porte, Indiana, United States
St. Luke's Hospital
Cedar Rapids, Iowa, United States
University of Iowa Hospitals and Clinics
Davenport, Iowa, United States
Via-Christi Regional Medical Center
Wichita, Kansas, United States
Norton Cardiovascular Associates
Louisville, Kentucky, United States
University of Maryland Medical System
Baltimore, Maryland, United States
Steward St. Elizabeth's Medical Center of Boston, Inc.
Boston, Massachusetts, United States
St. John Hospital & Medical Center
Detroit, Michigan, United States
Sparrow Health System
Lansing, Michigan, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
Cox Health
Springfield, Missouri, United States
St. Patrick Hospital
Missoula, Montana, United States
Rochester General Hospital
Rochester, New York, United States
Wake Medical Center
Raleigh, North Carolina, United States
Summa Health System
Akron, Ohio, United States
Lindner Center for Research and Education
Cincinnati, Ohio, United States
St. Elizabeth Health Center
Poland, Ohio, United States
Good Samaritan Hospital
Lebanon, Pennsylvania, United States
University Medical Center-Greenville Memorial Hospital
Greenville, South Carolina, United States
Seton Medical Center
Austin, Texas, United States
Cardiology Clinic of San Antonio
San Antonio, Texas, United States
University of Utah Hospital and Clinics
Salt Lake City, Utah, United States
Virginia Commonwealth University Health
Richmond, Virginia, United States
PeaceHealth Southwest Medical
Vancouver, Washington, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
Countries
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Other Identifiers
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IDE# G130241
Identifier Type: OTHER
Identifier Source: secondary_id
CAPTIVATE
Identifier Type: -
Identifier Source: org_study_id
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