3T MRI CIED Post-Approval Study



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:5/5/2018
Start Date:April 2016
End Date:July 2020
Contact:Medtronic Product Surveillance Registry
Email:rs.productsurveillanceregistry@medtronic.com

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Trial Summary
Trial Overview
Inclusion Criteria

Pacing Capture Threshold Change Following 3T MRI Scan of MR Conditional Cardiac Implantable Electronic Devices

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).


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 qualifying
Medtronic 3T MR Conditional CIED system

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
64
sites
Clinical Trial Facility in Chula Vista California
Chula Vista, California 91910
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Chula Vista, CA
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Clinical Trial Facility in Akron Ohio
Akron, Ohio
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Akron, OH
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Clinical Trial Facility in Albany Georgia
Albany, Georgia
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Albany, GA
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Clinical Trial Facility in Albuquerque New Mexico
Albuquerque, New Mexico
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Albuquerque, NM
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Clinical Trial Facility in Allentown Pennsylvania
Allentown, Pennsylvania
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Allentown, PA
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Clinical Trial Facility in Anchorage Alaska
Anchorage, Alaska
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Anchorage, AK
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Clinical Trial Facility in Austin Texas
Austin, Texas 78744
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Austin, TX
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Clinical Trial Facility in Bakersfield California
Bakersfield, California 93301
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Bakersfield, CA
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Clinical Trial Facility in Baltimore Maryland
Baltimore, Maryland
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Baltimore, MD
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Clinical Trial Facility in Boston Massachusetts
Boston, Massachusetts
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Boston, MA
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Clinical Trial Facility in Bronx New York
Bronx, New York
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Bronx, NY
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Clinical Trial Facility in Burlington Vermont
Burlington, Vermont 05401
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Burlington, VT
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Clinical Trial Facility in Cincinnati Ohio
Cincinnati, Ohio
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Cincinnati, OH
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Clinical Trial Facility in Clearwater Florida
Clearwater, Florida 33756
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Clearwater, FL
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Clinical Trial Facility in Colorado Springs Colorado
Colorado Springs, Colorado 80910
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Colorado Springs, CO
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Clinical Trial Facility in Columbia Missouri
Columbia, Missouri 65201
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Columbia, MO
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Clinical Trial Facility in Coon Rapids Minnesota
Coon Rapids, Minnesota
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Coon Rapids, MN
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Clinical Trial Facility in Danville Pennsylvania
Danville, Pennsylvania
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Danville, PA
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Clinical Trial Facility in Durham North Carolina
Durham, North Carolina
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Durham, NC
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Clinical Trial Facility in Edgewood Kentucky
Edgewood, Kentucky
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Edgewood, KY
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Clinical Trial Facility in Erie Pennsylvania
Erie, Pennsylvania 16502
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Erie, PA
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Clinical Trial Facility in Falls Church Virginia
Falls Church, Virginia 22042
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Falls Church, VA
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Clinical Trial Facility in Fort Worth Texas
Fort Worth, Texas
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Fort Worth, TX
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Clinical Trial Facility in Garden City New York
Garden City, New York 11530
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Garden City, NY
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Clinical Trial Facility in Gasthuisberg
Gasthuisberg, 3001
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Gasthuisberg,
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Clinical Trial Facility in Germantown Tennessee
Germantown, Tennessee 38138
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Germantown, TN
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Clinical Trial Facility in Gilbert Arizona
Gilbert, Arizona 85234
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Gilbert, AZ
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Clinical Trial Facility in Henderson Nevada
Henderson, Nevada
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Henderson, NV
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Clinical Trial Facility in Huntington New York
Huntington, New York
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Huntington, NY
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Clinical Trial Facility in Indianapolis Indiana
Indianapolis, Indiana 46202
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Indianapolis, IN
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Clinical Trial Facility in Jonesboro Arkansas
Jonesboro, Arkansas
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Jonesboro, AR
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Clinical Trial Facility in Kansas City Kansas
Kansas City, Kansas
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Kansas City, KS
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Clinical Trial Facility in Louisville Kentucky
Louisville, Kentucky 40202
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Louisville, KY
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Clinical Trial Facility in Madison Wisconsin
Madison, Wisconsin 53792
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Madison, WI
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Clinical Trial Facility in Marietta Georgia
Marietta, Georgia 30060
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Marietta, GA
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Clinical Trial Facility in Milwaukee Wisconsin
Milwaukee, Wisconsin 53226
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Milwaukee, WI
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Clinical Trial Facility in Minneapolis Minnesota
Minneapolis, Minnesota 55455
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Minneapolis, MN
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Clinical Trial Facility in Morristown New Jersey
Morristown, New Jersey 07960
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Morristown, NJ
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Clinical Trial Facility in Nashville Tennessee
Nashville, Tennessee 37232
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Nashville, TN
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Clinical Trial Facility in New Haven Connecticut
New Haven, Connecticut
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New Haven, CT
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Clinical Trial Facility in New York New York
New York, New York 10032
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New York, NY
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Clinical Trial Facility in Philadelphia Pennsylvania
Philadelphia, Pennsylvania
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Philadelphia, PA
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Clinical Trial Facility in Pittsburgh Pennsylvania
Pittsburgh, Pennsylvania
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Pittsburgh, PA
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Clinical Trial Facility in Plano Texas
Plano, Texas 75024
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Plano, TX
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Clinical Trial Facility in Portland Oregon
Portland, Oregon
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Portland, OR
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Clinical Trial Facility in Poughkeepsie New York
Poughkeepsie, New York 12601
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Poughkeepsie, NY
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Clinical Trial Facility in Raleigh North Carolina
Raleigh, North Carolina 27607
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Raleigh, NC
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Clinical Trial Facility in Redwood City California
Redwood City, California 94062
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Redwood City, CA
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Clinical Trial Facility in Robbinsdale Minnesota
Robbinsdale, Minnesota
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Robbinsdale, MN
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Clinical Trial Facility in Rochester Minnesota
Rochester, Minnesota 55905
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Rochester, MN
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Clinical Trial Facility in Safety Harbor Florida
Safety Harbor, Florida 34695
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Safety Harbor, FL
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Clinical Trial Facility in Saint Louis Missouri
Saint Louis, Missouri 63110
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Saint Louis, MO
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Clinical Trial Facility in Saint Louis Park Minnesota
Saint Louis Park, Minnesota
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Saint Louis Park, MN
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Clinical Trial Facility in Salisbury Maryland
Salisbury, Maryland 21801
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Salisbury, MD
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Clinical Trial Facility in San Antonio Texas
San Antonio, Texas 78224
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San Antonio, TX
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Clinical Trial Facility in San Diego California
San Diego, California
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San Diego, CA
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Clinical Trial Facility in San Francisco California
San Francisco, California
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San Francisco, CA
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Clinical Trial Facility in Silver Spring Maryland
Silver Spring, Maryland
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Silver Spring, MD
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Clinical Trial Facility in Spokane Washington
Spokane, Washington
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Spokane, WA
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Clinical Trial Facility in Stanford California
Stanford, California 94305
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Stanford, CA
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Clinical Trial Facility in Toledo Ohio
Toledo, Ohio 43608
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Toledo, OH
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Clinical Trial Facility in Utica New York
Utica, New York
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Utica, NY
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Clinical Trial Facility in Wilkes-Barre Pennsylvania
Wilkes-Barre, Pennsylvania 18711
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Wilkes-Barre, PA
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Clinical Trial Facility in Ypsilanti Michigan
Ypsilanti, Michigan 48197
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Ypsilanti, MI
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