Model 4965 Post-Approval Study

NCT01076348 | Completed Results

• 1 other identifier: 4965
• Study Type: observational
• Target: 73
• Locations: 12 countries
• Sites: 105

Brief Summary

Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).

Conditions

Heart Failure; Pacing; Bradycardia; Arrhythmia

Keywords

Epicardial; Pacing Lead

Outcome Measures

Primary Outcomes (1)

• Model 4965 Complication Free Rate

  A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed.

  1 year

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects 19 years or older implanted with Model 4965 Capsure Epi Lead.

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 (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.

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 SLS 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 (107)

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Birmingham, Alabama, United States

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Anchorage, Alaska, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, 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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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

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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

Heart Failure; Bradycardia; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study cohort was limited to subjects \>19 years of age at the time of implant, limiting the survival analysis of the Model 4965 lead in a pediatric population.

Results Point of Contact

• Title: Stefanie Lorinser, Sr. Clinical Research Specialist
• Organization: Medtronic, Inc.

stefanie.lorinser@medtronic.com

763-526-2742

Study Officials

• 4965 Post-Approval Study Clinical Trial Leader

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 26, 2010
• Study Start: September 1, 1996
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 27, 2019
• Results First Posted: August 23, 2012

Record last verified: 2019-02

Locations

US (84); DE (1); NL (2); ES (1); DK (1); CA (7); SE (1); CH (1); IT (3); BE (1); FR (1); AU (2)