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Arrhythmia4968NCT01076361

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

An observational study of Arrhythmia and Heart Failure, run by Medtronic at 106 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Arrhythmia, Heart Failure
How many people
370 participants
Where
106 sitesin 14 countries
Study dates
Sep 1999to Sep 2010
How long will I take part?
5 Years
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Subjects implanted with a 4968 lead.

Who may be able to join

  • 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

Who cannot join

  • 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
  • Subjects with exclusion criteria required by local law

Trial locations and contacts

106 sites in 14 countries.

106 sites in 14 countries

United States83 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Alexandria, Louisiana

  • Study site

    Amarillo, Texas

  • Alaska Heart Institute

    Anchorage, Alaska

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Bakersville, California

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Browns Mills, New Jersey

  • Study site

    Burlington, Vermont

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chesapeake, Virginia

  • Study site

    Chula Vista, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Georgia

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Des Moines, Iowa

  • Study site

    Downey, California

  • Study site

    Doylestown, Pennsylvania

  • Study site

    East Palo Alto, California

  • Study site

    Fairfax, Virginia

  • Study site

    Florence, South Carolina

  • Study site

    Fort Worth, Texas

  • Study site

    Germantown, Tennessee

  • Study site

    Gilbert, Arizona

  • Study site

    Grand Blanc, Michigan

  • Study site

    Greensboro, North Carolina

  • Study site

    Hickory, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Jacksonville, Florida

  • Study site

    Kansas City, Kansas

  • Study site

    Kansas City, Missouri

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Lebanon, New Hampshire

  • Study site

    Lexington, Kentucky

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Madison, Wisconsin

  • Study site

    Marietta, Georgia

  • Study site

    Marquette, Michigan

  • Study site

    Melbourne, Florida

  • Study site

    Memphis, Tennessee

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Mineola, New York

  • Study site

    Nashville, Tennessee

  • Study site

    Newark, New Jersey

  • Study site

    Newburgh, Indiana

  • Study site

    Oak Lawn, Illinois

  • Study site

    Ocala, Florida

  • Study site

    Ocean City, New Jersey

  • Study site

    Olympia, Washington

  • Study site

    Parlin, New Jersey

  • Study site

    Portland, Oregon

  • Study site

    Robbinsdale, Minnesota

  • Study site

    Rochester, Minnesota

  • Study site

    Rochester, New York

  • Study site

    Saginaw, Michigan

  • Study site

    Saint Paul, Minnesota

  • Study site

    Salinas, California

  • Study site

    Salisbury, Maryland

  • Study site

    San Antonio, Texas

  • Study site

    Sayre, Pennsylvania

  • Study site

    Scottsdale, Arizona

  • Study site

    Silver Spring, Maryland

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Southfield, Michigan

  • Study site

    Spokane, Washington

  • Study site

    The Woodlands, Texas

  • Study site

    Toledo, Ohio

  • Study site

    Torrance, California

  • Study site

    Towson, Maryland

  • Study site

    Van Nuys, California

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Wellington, Florida

  • Study site

    West Orange, New Jersey

Other trials in United States

Canada7 sites

  • Study site

    Calgary, Alberta

  • Study site

    Hamilton, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Ottawa, Ontario

  • Study site

    Regina, Saskatchewan

  • Study site

    Ste-Foy, Quebec

  • Study site

    Toronto, Ontario

Other trials in Canada

Italy3 sites

  • Study site

    Catanzaro

  • Study site

    Reggio Emilia

  • Study site

    Udine

Other trials in Italy

Austria2 sites

  • Study site

    Linz

  • Study site

    Vienna

Other trials in Austria

Netherlands2 sites

  • Study site

    Eindhoven

  • Study site

    Rotterdam

Other trials in Netherlands

Australia1 site

  • Study site

    Bedford Park, South Australia

Other trials in Australia

Belgium1 site

  • Study site

    Hasselt

Other trials in Belgium

Denmark1 site

  • Study site

    Copenhagen

Other trials in Denmark

France1 site

  • Study site

    Marseille

Other trials in France

Germany1 site

  • Study site

    Homburg/Saar

Other trials in Germany

Serbia and Montenegro1 site

  • Study site

    Belgrade

Other trials in Serbia and Montenegro

Spain1 site

  • Study site

    Valencia

Other trials in Spain

Sweden1 site

  • Study site

    Skövde

Other trials in Sweden

Switzerland1 site

  • Study site

    Zurich

Other trials in Switzerland

About this study

Official title: Medtronic Model 4968 CapSure Epi® Steroid-Eluting Bipolar Epicardial Pacing Lead Post-approval Study

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.

Read the detailed description

The Medtronic CapSure Epi Lead Post-approval Study is being conducted as part of the requirements to satisfy the PMA conditions of approval for the Model 4968 lead. 100 subjects (adult and pediatric) with a 4968 lead will be followed for a minimum of five years to assess the long-term safety of the leads.

Keywords
Epicardial, Pacing Lead
Medical subject headings
Arrhythmias, Cardiac, Heart Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2010 (estimated)
  2. Study startSep 1999
  3. Primary completionSep 2010
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
370 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT01076361
Sponsor's protocol ID
4968
Acronym
4968
Status last verified
Oct 2014
First submitted
24 Feb 2010
Last updated
27 Oct 2014
Data monitoring committee
No

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