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

NCT ID: NCT01076361

Last Updated: 2014-10-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

370 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-09-30

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Arrhythmia Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

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 4968 Post-approval study center
* Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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4968 Clinical Trial Leader

Role: STUDY_CHAIR

Medtronic

Locations

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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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Countries

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United States Australia Austria Belgium Canada Denmark France Germany Italy Netherlands Serbia and Montenegro Spain Sweden Switzerland

Other Identifiers

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4968

Identifier Type: -

Identifier Source: org_study_id

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