Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study

NCT01076361 | Completed Results

• 1 other identifier: 4968
• Study Type: observational
• Target: 370
• Locations: 12 countries
• Sites: 104

Brief Summary

The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead. This study is part of the Medtronic System Longevity Study.

Conditions

Arrhythmia; Heart Failure

Keywords

Epicardial; Pacing Lead

Outcome Measures

Primary Outcomes (1)

• Survival Probability of the Model 4968 Lead Based on Lead-related Complications

  The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability.

  The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety.

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 4968 lead.

You may qualify if:

• Provision of written informed consent and/or authorization for access to and use of health information by subjects or appropriate legal guardians as required by an institution's Investigational Review Board, Medical Ethics Board, or Research Ethics Board
• Availability of implant, follow-up, and product-related event data
• Implanted with a Model 4968 Capsure Epi Lead

You may not qualify if:

• Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
• Subjects who are, or will be inaccessible for follow-up at a 4968 Post-approval study center
• Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded

Sponsors & Collaborators

• Medtronic: lead

Study Sites (106)

Alaska Heart Institute

Anchorage, Alaska, United States

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Gilbert, Arizona, United States

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Scottsdale, Arizona, United States

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Little Rock, Arkansas, United States

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Bakersville, 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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Los Angeles, California, United States

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Salinas, 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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Washington D.C., District of Columbia, 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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Ocala, Florida, United States

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Wellington, Florida, 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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Indianapolis, Indiana, United States

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Newburgh, 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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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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Salisbury, Maryland, United States

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Silver Spring, Maryland, United States

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Towson, Maryland, United States

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Grand Blanc, Michigan, United States

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Marquette, Michigan, United States

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Saginaw, Michigan, United States

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Southfield, Michigan, United States

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Robbinsdale, Minnesota, United States

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Rochester, Minnesota, United States

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Saint Paul, Minnesota, United States

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Kansas City, 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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Newark, 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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Mineola, New York, United States

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Rochester, New York, United States

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Greensboro, North Carolina, United States

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Hickory, North Carolina, 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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Doylestown, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Sayre, Pennsylvania, 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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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Amarillo, Texas, 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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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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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Bedford Park, South Australia, Australia

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Linz, Austria

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Vienna, Austria

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Hasselt, Belgium

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Calgary, Alberta, Canada

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Hamilton, 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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Ste-Foy, 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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Homburg/Saar, Germany

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Catanzaro, Italy

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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 and Montenegro

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Valencia, Spain

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Skövde, Sweden

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Zurich, Switzerland

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MeSH Terms

Conditions

Arrhythmias, Cardiac; Heart Failure

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: 4968 Clinical Trial Leader
• Organization: Medtronic

medtroniccrmtrials@medtronic.com

Study Officials

• 4968 Clinical Trial Leader

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 26, 2010
• Study Start: September 1, 1999
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 27, 2014
• Results First Posted: October 27, 2014

Record last verified: 2014-10

Locations

SE (1); ES (1); CH (1); US (83); FR (1); DK (1); AU (2); IT (3); BE (1); DE (1); NL (2); CA (7)