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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COMPLETED
73 participants
OBSERVATIONAL
1996-09-30
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
AND one of the following (A, B, or C) must also apply:
A. Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a market-released IPG, ICD, or CRT Device. The Medtronic lead must be used for a pacing, sensing, or defibrillation application.
B. Subjects who participated in a qualifying study of a Medtronic cardiac therapy product and for whom:
* product is market-released
* complete implant and follow-up data, including product-related adverse events, are available
* subject or appropriate legal guardian authorizes release of subject study data to SLS C. Subjects implanted with Medtronic CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements. Post approval requirements indicate 50 adult subjects implanted with a model 4965 and 100 subjects (pediatric and adult) implanted with a model 4968. The study plans to enroll approximately 100 subjects with a model 4965 lead and approximately 200 subjects with a model 4968 lead.
Note: Subjects currently active in the Chronic Lead Study or Tachyarrhythmia Chronic Systems Study will continue in the follow-up phase of the SLS.
Exclusion Criteria
* Subjects who are, or will be inaccessible for follow-up at a SLS center
* Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded
19 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Responsible Party
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Principal Investigators
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4965 Post-Approval Study Clinical Trial Leader
Role: STUDY_CHAIR
Medtronic
Locations
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Birmingham, Alabama, United States
Anchorage, Alaska, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
Bakersfield, California, United States
Chula Vista, California, United States
Downey, California, United States
East Palo Alto, California, United States
Los Angeles, California, United States
Salinas, California, United States
Torrance, California, United States
Van Nuys, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Melbourne, Florida, United States
Ocala, Florida, United States
Wellington, Florida, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Marietta, Georgia, United States
Oak Lawn, Illinois, United States
Indianapolis, Indiana, United States
Newburgh, Indiana, United States
Des Moines, Iowa, United States
Kansas City, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Alexandria, Louisiana, United States
Baton Rouge, Louisiana, United States
Salisbury, Maryland, United States
Silver Spring, Maryland, United States
Towson, Maryland, United States
Grand Blanc, Michigan, United States
Marquette, Michigan, United States
Saginaw, Michigan, United States
Southfield, Michigan, United States
Robbinsdale, Minnesota, United States
Rochester, Minnesota, United States
Saint Paul, Minnesota, United States
Kansas City, Missouri, United States
Lebanon, New Hampshire, United States
Browns Mills, New Jersey, United States
Newark, New Jersey, United States
Ocean City, New Jersey, United States
Parlin, New Jersey, United States
West Orange, New Jersey, United States
Albuquerque, New Mexico, United States
Mineola, New York, United States
Rochester, New York, United States
Greensboro, North Carolina, United States
Hickory, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Portland, Oregon, United States
Doylestown, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Sayre, Pennsylvania, United States
Columbia, South Carolina, United States
Florence, South Carolina, United States
Sioux Falls, South Dakota, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
Burlington, Vermont, United States
Chesapeake, Virginia, United States
Fairfax, Virginia, United States
Olympia, Washington, United States
Spokane, Washington, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Bedford Park, South Australia, Australia
Linz, , Austria
Vienna, , Austria
Hasselt, , Belgium
Calgary, Alberta, Canada
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Ste-Foy, Quebec, Canada
Regina, Saskatchewan, Canada
Copenhagen, , Denmark
Marseille, , France
Homburg/Saar, , Germany
Catanzaro, , Italy
Reggio Emilia, , Italy
Udine, , Italy
Eindhoven, , Netherlands
Rotterdam, , Netherlands
Belgrade, , Serbia
Valencia, , Spain
Skövde, , Sweden
Zurich, , Switzerland
Countries
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Other Identifiers
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4965
Identifier Type: -
Identifier Source: org_study_id
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