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Last updated on May 2019

3T MRI CIED Post-Approval Study

Brief description of study

The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT) measurements following 3T MRI scan exposure. This study is required by FDA as a condition of approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted within Medtronic's post-market surveillance platform, the Product Surveillance Registry (PSR).

Clinical Study Identifier: NCT02969395

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Medtronic Product Surveillance Registry

Birmingham, AL United States

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Anchorage, AK United States

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Chandler, AZ United States

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Jonesboro, AR United States

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Little Rock, AR United States

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Bakersfield, CA United States

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Chula Vista, CA United States

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La Quinta, CA United States

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Rancho Mirage, CA United States

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Redwood City, CA United States

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Salinas, CA United States

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San Diego, CA United States

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San Francisco, CA United States

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Stanford, CA United States

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Torrance, CA United States

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Van Nuys, CA United States

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Colorado Springs, CO United States

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Denver, CO United States

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Lakewood, CO United States

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New Haven, CT United States

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Newark, DE United States

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Washington, WA United States

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Bradenton, FL United States

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Clearwater, FL United States

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Davenport, FL United States

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Tampa, FL United States

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Albany, GA United States

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Marietta, GA United States

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Coeur d'Alene, ID United States

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Chicago, IL United States

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Evansville, IN United States

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Indianapolis, IN United States

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Des Moines, IA United States

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Kansas City, KS United States

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Edgewood, KY United States

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Louisville, KY United States

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Baton Rouge, LA United States

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Baltimore, MD United States

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Salisbury, MD United States

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Silver Spring, MD United States

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Takoma Park, MD United States

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Boston, MA United States

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Marquette, MI United States

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Ypsilanti, MI United States

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Minneapolis, MN United States

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Robbinsdale, MN United States

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Rochester, MN United States

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Saint Louis Park, MN United States

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Columbia, MO United States

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Saint Louis, MO United States

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Henderson, NV United States

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Eatontown, NJ United States

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Morristown, NJ United States

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Albuquerque, NM United States

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Bay Shore, NY United States

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Garden City, NY United States

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Huntington, NY United States

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Manhasset, NY United States

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New York, NY United States

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Poughkeepsie, NY United States

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Suffern, NY United States

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Utica, NY United States

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Durham, NC United States

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Raleigh, NC United States

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Akron, OH United States

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Cincinnati, OH United States

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Cleveland, OH United States

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Toledo, OH United States

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Portland, OR United States

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Allentown, PA United States

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Bethlehem, PA United States

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Danville, PA United States

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Erie, PA United States

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Philadelphia, PA United States

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Pittsburgh, PA United States

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Wilkes-Barre, PA United States

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Germantown, TN United States

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Nashville, TN United States

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Austin, TX United States

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Fort Worth, TX United States

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Houston, TX United States

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Plano, TX United States

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San Antonio, TX United States

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Burlington, VT United States

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Arlington, VA United States

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Charlottesville, VA United States

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Madison, WI United States

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Milwaukee, WI United States

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Dinant, Belgium

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Leuven, Belgium

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Kingston, ON Canada

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Sainte-Foy, QC Canada

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Trois-Rivières, QC Canada

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Calgary, Canada

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Montreal, Canada

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Ottawa, Canada

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Clermont-Ferrand, France

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La Rochelle, France

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Metz-Tessy, France

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Nantes, France

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Essen, Germany

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Hannover, Germany

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Homburg, Germany

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Köln, Germany

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Tübingen, Germany

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Ulm, Germany

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Milan, Italy

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Kuala Lumpur, Malaysia

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Eindhoven, Netherlands

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Maastricht, Netherlands

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Nieuwegein, Netherlands

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Rotterdam, Netherlands

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La Coruña, Spain

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Palma De Mallorca, Spain

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Zurich, Switzerland

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Liverpool, United Kingdom

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Manchester, United Kingdom

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Middlesbrough, United Kingdom

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Trois-Rivières, QC Canada

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Köln, Germany

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Tübingen, Germany

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La Coruña, Spain

Recruitment Status: Open

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