MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY

NCT01076374 | Completed

• 1 other identifier: nEw3 PAS
• Study Type: observational
• Target: 2,927
• Locations: 11 countries
• Sites: 128

Brief Summary

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).

Conditions

Arrhythmia; Bradycardia

Keywords

pacemaker

Outcome Measures

Primary Outcomes (1)

• Rate of device malfunctions

  5 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects implanted with a Medtronic Adapta®, Sensia™, or Versa™ IPG.

You may qualify if:

• 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.

You may not qualify if:

• Subjects who are, or will be inaccessible for follow-up at a SLS center
• 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

Sponsors & Collaborators

• Medtronic: lead

Study Sites (129)

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Birmingham, Alabama, United States

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Anchorage, Alaska, United States

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Gilbert, Arizona, United States

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Scottsdale, Arizona, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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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 Springs, Colorado, United States

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Denver, Colorado, United States

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Newark, Delaware, United States

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Washington D.C., District of Columbia, United States

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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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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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Oak Lawn, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Kansas City, Kansas, United States

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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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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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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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Worcester, Massachusetts, United States

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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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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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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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Lebanon, New Hampshire, United States

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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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Albuquerque, New Mexico, United States

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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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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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Fargo, North Dakota, United States

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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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Portland, Oregon, United States

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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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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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Sioux Falls, South Dakota, United States

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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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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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Burlington, Vermont, United States

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Chesapeake, Virginia, United States

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Fairfax, Virginia, United States

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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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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Linz, Austria

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Hasselt, Belgium

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Calgary, Alberta, Canada

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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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Montreal, Quebec, Canada

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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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Zurich, Switzerland

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MeSH Terms

Conditions

Arrhythmias, Cardiac; Bradycardia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• nEw3 PAS Clinical Trial Leader

  Medtronic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 26, 2010
• Study Start: July 1, 2008
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

US (110); BE (1); IT (2); SE (1); DK (1); FR (2); CH (1); NL (2); AU (1); DE (1); CA (6)