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Clinical Trial Details

Overview

Research Study Summary

A clinical research study for the treatment of Arrhythmia or Heart Failure

Research Study Title

Medtronic Model 4968 CapSure EpiĀ® Steroid-Eluting Bipolar Epicardial Pacing Lead Post-approval Study

Purpose

The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead. This study is part of the Product Performance Platform (PPP).

To Learn more
Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Lead Sponsor

Medtronic Cardiac Rhythm Disease Management

Duration

132 Months

Facility Type

N/A

Eligibility

Both Male and Female ages up to N/A

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

  • Subjects with exclusion criteria required by local law

Site Locations (107)

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

Contact

4968 Clinical Trial Leader

E-mail:

NCT ID: NCT01076361

Date Last Changed: March 21, 2011

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