MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY
NCT ID: NCT01076374
Last Updated: 2018-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2927 participants
OBSERVATIONAL
2008-07-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
AND one of the following must also apply:
* Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a Medtronic Adapta®, Sensia™, or Versa™ IPG. The Medtronic lead must be used for pacing, sensing or defibrillation application.
* Subjects who participated in a qualifying study (IDE) of a Medtronic cardiac therapy product and: 1) have a Medtronic Adapta®, Sensia™, or Versa™ IPG 2)product is market-released 3) complete implant and follow-up data, including product-related adverse events are available and 4) subject of appropriate legal guardian authorizes release of subject study data to SLS
* Subjects implanted with a Medtronic Adapta®, Sensia™, or Versa™ IPG and Medtronic CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements.
Exclusion Criteria
* Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
* Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded
ALL
No
Sponsors
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Medtronic
INDUSTRY
Responsible Party
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Principal Investigators
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nEw3 PAS Clinical Trial Leader
Role: STUDY_CHAIR
Medtronic
Locations
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Birmingham, Alabama, United States
Anchorage, Alaska, United States
Gilbert, Arizona, United States
Scottsdale, Arizona, United States
Jonesboro, Arkansas, 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
La Jolla, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Redding, California, United States
Salinas, California, United States
San Diego, California, United States
Santa Rosa, California, United States
Torrance, California, United States
Van Nuys, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Newark, Delaware, United States
Washington D.C., District of Columbia, United States
Bradenton, Florida, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Melbourne, Florida, United States
Tampa, Florida, United States
Albany, Georgia, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Marietta, Georgia, United States
Oak Lawn, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Des Moines, Iowa, United States
Kansas City, Kansas, United States
Edgewood, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Alexandria, Louisiana, United States
Baton Rouge, Louisiana, United States
Covington, Louisiana, United States
Salisbury, Maryland, United States
Silver Spring, Maryland, United States
Takoma Park, Maryland, United States
Towson, Maryland, United States
Worcester, Massachusetts, United States
Lansing, Michigan, United States
Marquette, Michigan, United States
Saginaw, Michigan, United States
Ypsilanti, Michigan, United States
Coon Rapids, Minnesota, United States
Minneapolis, Minnesota, United States
Robbinsdale, Minnesota, United States
Rochester, Minnesota, United States
Saint Louis Park, Minnesota, United States
Saint Paul, Minnesota, United States
Columbia, Missouri, United States
Kansas City, Missouri, United States
Washington, Missouri, United States
Lebanon, New Hampshire, United States
Browns Mills, 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
Garden City, New York, United States
Henderson, New York, United States
Huntington, New York, United States
Poughkeepsie, New York, United States
Rochester, New York, United States
Utica, New York, United States
Durham, North Carolina, United States
Greensboro, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Portland, Oregon, United States
Erie, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Sayre, Pennsylvania, United States
Charleston, South Carolina, 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
Kingsport, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Plano, 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
Tacoma, Washington, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Linz, , Austria
Hasselt, , Belgium
Calgary, Alberta, Canada
Kingston, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Regina, Saskatchewan, Canada
Copenhagen, , Denmark
Marseille, , France
Nantes, , France
Homburg/Saar, , Germany
Reggio Emilia, , Italy
Udine, , Italy
Eindhoven, , Netherlands
Rotterdam, , Netherlands
Belgrade, , Serbia
Skövde, , Sweden
Zurich, , Switzerland
Countries
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Other Identifiers
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nEw3 PAS
Identifier Type: -
Identifier Source: org_study_id
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