DF4 Connector System Post-Approval Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:3/22/2019
Start Date:January 2012
End Date:March 2019

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The purpose of this study is to evaluate long-term performance of the DF4 Connector System.
This evaluation is based on the number of DF4 lead-related complications occurring during the
study compared to the number of leads enrolled in the study. The DF4 systems will be followed
for 5 years after implant. This study is required by FDA as a condition of approval of the
DF4 Connector Systems. This study is conducted within Medtronic's post-market surveillance
platform.


Inclusion Criteria:

- Subject or legally authorized representative provides written authorization and/or
consent per institution and geographical requirements

- Subject is intended to be implanted or is within 30 days post-implant of a DF4
Connector System with a Medtronic DF4 lead used for a pacing, sensing and/or
defibrillation application

Exclusion Criteria:

- Subject who is, or will be inaccessible for follow-up at a study site

- Subject with exclusion criteria required by local law (Europe, Central Asia [ECA]
only)

- Implant and follow-up data, including any adverse device effects and system
modifications at implant through the time of enrollment are unavailable
We found this trial at
73
sites
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Louisville, KY
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Akron, OH
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Albany, GA
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Albuquerque, NM
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Allentown, PA
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Anchorage, AK
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Atlanta, GA
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Austin, TX
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Bakersfield, CA
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Baton Rouge, LA
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Birmingham, AL
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Bradenton, FL
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Burlington, VT
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Calgary,
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Chula Vista, CA
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Cincinnati, OH
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Clearwater, FL
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Cleveland, OH
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Colorado Springs, Colorado 80910
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Colorado Springs, CO
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Columbia, MO
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Des Moines, IA
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Durham, NC
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Edgewood, KY
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Erie, PA
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Garden City, NY
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Germantown, TN
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Gilbert, AZ
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Henderson, NV
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Huntington, NY
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Hyattsville, MD
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Indianapolis, IN
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Jonesboro, AR
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Kansas City, KS
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Kansas City, MO
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Kingsport, TN
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Lakewood, CO
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Lancaster, PA
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Lansing, MI
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Little Rock, AR
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Madison, WI
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Marietta, GA
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Marquette, MI
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Milwaukee, WI
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Morristown, NJ
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Nashville, TN
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New York, NY
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Newark, DE
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Olympia, WA
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Philadelphia, PA
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Pittsburgh, PA
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Plano, TX
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Poughkeepsie, NY
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Raleigh, NC
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Rancho Mirage, California 90070
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Rancho Mirage, CA
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Robbinsdale, MN
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Saint Louis, MO
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Saint Louis Park, MN
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Saint Paul, MN
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Salinas, CA
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San Diego, CA
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San Francisco, CA
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Scottsdale, AZ
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Spokane, WA
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Tacoma, WA
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Takoma Park, MD
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The Woodlands, TX
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Toledo, OH
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Torrance, CA
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Utica, NY
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Van Nuys, CA
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Washington,
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Winston-Salem, NC
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Worcester, MA
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