Model 4965 Post-Approval Study

February 11, 2019 updated by: Medtronic

Medtronic Model 4965 Capsure Epi® Steroid-eluting Unipolar Epicardial Pacing Lead Post Approval Study

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

Study Overview

Status

Completed

Conditions

Detailed Description

As part of the requirement to satisfy the PMA Conditions of Approval for the Medtronic Model 4965 CapSure Epi® Steroid-Eluting Unipolar Epicardial Pacing Lead, 50 adult subjects who were ≥19 years old at time of implant were followed for one-year post-implant.

Study Type

Observational

Enrollment (Actual)

73

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

  • Australia
    • South Australia
      • Bedford Park, South Australia, Australia
  • Austria
      • Linz, Austria
      • Vienna, Austria
  • Belgium
      • Hasselt, Belgium
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Ste-Foy, Quebec, Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada
  • Denmark
      • Copenhagen, Denmark
  • France
      • Marseille, France
  • Germany
      • Homburg/Saar, Germany
  • Italy
      • Catanzaro, Italy
      • Reggio Emilia, Italy
      • Udine, Italy
  • Netherlands
      • Eindhoven, Netherlands
      • Rotterdam, Netherlands
  • Serbia
      • Belgrad, Serbia
  • Spain
      • Valencia, Spain
  • Sweden
      • Skovde, Sweden
  • Switzerland
      • Zurich, Switzerland
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Alaska
      • Anchorage, Alaska, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Scottsdale, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Bakersfield, California, United States
      • Chula Vista, California, United States
      • Downey, California, United States
      • East Palo Alto, California, United States
      • Los Angeles, California, United States
      • Salinas, California, United States
      • Torrance, California, United States
      • Van Nuys, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
      • Denver, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Clearwater, Florida, United States
      • Jacksonville, Florida, United States
      • Melbourne, Florida, United States
      • Ocala, Florida, United States
      • Wellington, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Columbus, Georgia, United States
      • Marietta, Georgia, United States
    • Illinois
      • Oak Lawn, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
      • Newburgh, Indiana, United States
    • Iowa
      • Des Moines, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Alexandria, Louisiana, United States
      • Baton Rouge, Louisiana, United States
    • Maryland
      • Salisbury, Maryland, United States
      • Silver Spring, Maryland, United States
      • Towson, Maryland, United States
    • Michigan
      • Grand Blanc, Michigan, United States
      • Marquette, Michigan, United States
      • Saginaw, Michigan, United States
      • Southfield, Michigan, United States
    • Minnesota
      • Robbinsdale, Minnesota, United States
      • Rochester, Minnesota, United States
      • Saint Paul, Minnesota, United States
    • Missouri
      • Kansas City, Missouri, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Jersey
      • Browns Mills, New Jersey, United States
      • Newark, New Jersey, United States
      • Ocean City, New Jersey, United States
      • Parlin, New Jersey, United States
      • West Orange, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Mineola, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Greensboro, North Carolina, United States
      • Hickory, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Toledo, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Doylestown, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Sayre, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
      • Florence, South Carolina, United States
    • South Dakota
      • Sioux Falls, South Dakota, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Germantown, Tennessee, United States
      • Memphis, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Amarillo, Texas, United States
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
      • The Woodlands, Texas, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Chesapeake, Virginia, United States
      • Fairfax, Virginia, United States
    • Washington
      • Olympia, Washington, United States
      • Spokane, Washington, United States
    • Wisconsin
      • Madison, Wisconsin, United States
      • Milwaukee, Wisconsin, United States

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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 (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.

Exclusion Criteria:

  • 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
  • Subjects with exclusion criteria required by local law (EMEA only)

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
Measure Description
Time Frame
Model 4965 Complication Free Rate
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Investigators

  • Study Chair: 4965 Post-Approval Study 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

September 1, 1996

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

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)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4965

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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