- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01076374
MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY
April 24, 2018 updated by: Medtronic
Medtronic Adapta/Versa/Sensia Long Term Reliability Study
The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices.
This study is required by FDA as a condition of approval of nEw3 devices.
Patients will be followed for 5 years after implant.
This study utilizes data collected from the System Longevity Study (SLS).
Study Overview
Status
Completed
Conditions
Detailed Description
The rate of device malfunctions will be determined and a comparison to historical controls will be done.
Study Type
Observational
Enrollment (Actual)
2927
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Linz, Austria
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Hasselt, Belgium
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Alberta
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Calgary, Alberta, Canada
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Ontario
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Kingston, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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Saskatchewan
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Regina, Saskatchewan, Canada
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Copenhagen, Denmark
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Marseille, France
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Nantes, France
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Homburg/Saar, Germany
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Reggio Emilia, Italy
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Udine, Italy
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Eindhoven, Netherlands
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Rotterdam, Netherlands
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Belgrade, Serbia
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Skövde, Sweden
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Zürich, Switzerland
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Alabama
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Birmingham, Alabama, United States
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Alaska
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Anchorage, Alaska, United States
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Arizona
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Gilbert, Arizona, United States
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Scottsdale, Arizona, United States
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Arkansas
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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California
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Bakersfield, California, United States
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Chula Vista, California, United States
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Downey, California, United States
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East Palo Alto, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Redding, California, United States
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Salinas, California, United States
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San Diego, California, United States
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Santa Rosa, California, United States
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Torrance, California, United States
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Van Nuys, California, United States
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Colorado
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Delaware
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Newark, Delaware, United States
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District of Columbia
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Washington, District of Columbia, United States
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Florida
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Bradenton, Florida, United States
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Clearwater, Florida, United States
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Jacksonville, Florida, United States
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Melbourne, Florida, United States
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Tampa, Florida, United States
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Georgia
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Albany, Georgia, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Marietta, Georgia, United States
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Illinois
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Oak Lawn, Illinois, United States
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Indiana
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Iowa
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Des Moines, Iowa, United States
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Kansas
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Kansas City, Kansas, United States
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Kentucky
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Edgewood, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Louisiana
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Alexandria, Louisiana, United States
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Baton Rouge, Louisiana, United States
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Covington, Louisiana, United States
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Maryland
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Salisbury, Maryland, United States
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Silver Spring, Maryland, United States
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Takoma Park, Maryland, United States
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Towson, Maryland, United States
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Massachusetts
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Worcester, Massachusetts, United States
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Michigan
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Lansing, Michigan, United States
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Marquette, Michigan, United States
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Saginaw, Michigan, United States
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Ypsilanti, Michigan, United States
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Minnesota
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Coon Rapids, Minnesota, United States
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Minneapolis, Minnesota, United States
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Robbinsdale, Minnesota, United States
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Rochester, Minnesota, United States
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Saint Louis Park, Minnesota, United States
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Saint Paul, Minnesota, United States
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Missouri
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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Washington, Missouri, United States
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New Hampshire
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Lebanon, New Hampshire, United States
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New Jersey
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Browns Mills, New Jersey, United States
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Ocean City, New Jersey, United States
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Parlin, New Jersey, United States
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West Orange, New Jersey, United States
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New Mexico
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Albuquerque, New Mexico, United States
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New York
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Garden City, New York, United States
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Henderson, New York, United States
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Huntington, New York, United States
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Poughkeepsie, New York, United States
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Rochester, New York, United States
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Utica, New York, United States
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North Carolina
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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North Dakota
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Fargo, North Dakota, United States
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Ohio
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Toledo, Ohio, United States
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Oregon
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Portland, Oregon, United States
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Pennsylvania
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Erie, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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South Carolina
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Florence, South Carolina, United States
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South Dakota
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Sioux Falls, South Dakota, United States
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Tennessee
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Chattanooga, Tennessee, United States
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Germantown, Tennessee, United States
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Kingsport, Tennessee, United States
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Nashville, Tennessee, United States
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Texas
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Austin, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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The Woodlands, Texas, United States
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Vermont
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Burlington, Vermont, United States
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Virginia
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Chesapeake, Virginia, United States
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Fairfax, Virginia, United States
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Washington
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Olympia, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Wisconsin
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects implanted with a Medtronic Adapta®, Sensia™, or Versa™ IPG.
Description
Inclusion Criteria:
- Subjects or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC/REB.
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 who are, or will be inaccessible for follow-up at a SLS center
- Subjects with exclusion criteria required by local law (EMEA only)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Rate of device malfunctions
Time Frame: 5 years
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: nEw3 PAS Clinical Trial Leader, Medtronic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
February 24, 2010
First Submitted That Met QC Criteria
February 25, 2010
First Posted (Estimate)
February 26, 2010
Study Record Updates
Last Update Posted (Actual)
April 26, 2018
Last Update Submitted That Met QC Criteria
April 24, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- nEw3 PAS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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