3T MRI CIED Post-Approval Study
Pacing Capture Threshold Change Following 3T MRI Scan of MR Conditional Cardiac Implantable Electronic Devices
1 other identifier
observational
41
20 countries
202
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2016
Longer than P75 for all trials
202 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 10, 2016
CompletedFirst Posted
Study publicly available on registry
November 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2021
CompletedAugust 22, 2022
August 1, 2022
5.5 years
November 10, 2016
August 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of patients implanted with an MR Conditional CIED System with a pre-MRI to post-MRI scan PCT measure change of >0.5 Volts following 3T MRI scan exposure.
Patients will be followed for approximately 5 years.
Eligibility Criteria
Patients intended to be implanted or are within 30 days post-implant of a qualifying Medtronic 3T MR Conditional CIED system. All subjects must meet Inclusion criteria and none of the Exclusion criteria.
You may qualify if:
- 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
You may not qualify if:
- Subject who is, or will be inaccessible for follow-up at a study site
- Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtroniclead
Study Sites (204)
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Birmingham, Alabama, United States
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Anchorage, Alaska, United States
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Chandler, Arizona, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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Bakersfield, California, United States
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Chula Vista, California, United States
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La Quinta, California, United States
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Los Angeles, California, United States
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Palm Springs, California, United States
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Rancho Mirage, California, United States
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Redwood City, California, United States
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Salinas, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Stanford, California, United States
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Torrance, California, United States
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Van Nuys, California, United States
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Centennial, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Lakewood, Colorado, United States
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New Haven, Connecticut, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Bradenton, Florida, United States
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Clearwater, Florida, United States
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Davenport, Florida, United States
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Davie, Florida, United States
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Jacksonville, Florida, United States
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Panama City, Florida, United States
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Safety Harbor, Florida, United States
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Sebastian, Florida, United States
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Tampa, Florida, United States
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Albany, Georgia, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Coeur d'Alene, Idaho, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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West Des Moines, Iowa, United States
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Kansas City, Kansas, United States
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Edgewood, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Clinton, Maryland, United States
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Hyattsville, Maryland, United States
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Salisbury, Maryland, United States
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Silver Spring, Maryland, United States
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Takoma Park, Maryland, United States
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Boston, Massachusetts, United States
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Lansing, Michigan, United States
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Marquette, Michigan, United States
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Ypsilanti, Michigan, United States
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Coon Rapids, Minnesota, United States
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Minneapolis, Minnesota, United States
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Robbinsdale, Minnesota, United States
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Rochester, Minnesota, United States
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Saint Cloud, Minnesota, United States
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Saint Louis Park, Minnesota, United States
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Saint Paul, Minnesota, United States
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Hattiesburg, Mississippi, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Henderson, Nevada, United States
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Eatontown, New Jersey, United States
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Morristown, New Jersey, United States
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Ocean Township, New Jersey, United States
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Ridgewood, New Jersey, United States
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Albuquerque, New Mexico, United States
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Bay Shore, New York, United States
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Garden City, New York, United States
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Huntington, New York, United States
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Manhasset, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Poughkeepsie, New York, United States
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Staten Island, New York, United States
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Suffern, New York, United States
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The Bronx, New York, United States
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Utica, New York, United States
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Durham, North Carolina, United States
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Raleigh, North Carolina, United States
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Akron, Ohio, 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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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Allentown, Pennsylvania, United States
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Bethlehem, Pennsylvania, United States
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Danville, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Wilkes-Barre, Pennsylvania, United States
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Plano, 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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Tyler, Texas, United States
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Burlington, Vermont, United States
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Arlington, Virginia, United States
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Charlottesville, Virginia, United States
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Falls Church, Virginia, 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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Brussels, Belgium
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Dinant, Belgium
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Leuven, Belgium
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Liège, Belgium
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Yvoir, Belgium
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Kingston, Ontario, Canada
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Sainte-Foy, Quebec, Canada
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Calgary, Canada
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Montreal, Canada
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Ottawa, Canada
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Trois-Rivières, Canada
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Kunming, China
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Taiyuan, China
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Tianjin, China
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Copenhagen, Denmark
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Avignon, France
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Brest, France
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Clermont-Ferrand, France
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Dijon, France
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La Rochelle, France
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Metz-Tessy, France
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Montpellier, France
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Nantes, France
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Paris, France
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Pringy, France
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Saint-Priest-en-Jarez, France
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Aachen, Germany
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Cologne, Germany
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Essen, Germany
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Hanover, Germany
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Homburg, Germany
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Tübingen, Germany
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Ulm, Germany
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Athens, Greece
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Budapest, Hungary
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Castrovillari, Italy
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Lecce, Italy
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Milan, Italy
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Udine, Italy
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Fuchū, Japan
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Hidaka, Japan
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Hirosaki, Japan
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Hiroshima, Japan
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Kawasaki, Japan
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Kitakyushu, Japan
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Kyoto, Japan
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Ōsaka-sayama, Japan
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Sapporo, Japan
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Toyoake, Japan
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Urasoe, Japan
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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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Creixomil, Portugal
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Belgrade, Serbia
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Košice, Slovakia
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Ljubljana, Slovenia
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Busan, South Korea
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Changwon, South Korea
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Daegu, South Korea
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Gangneung, South Korea
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Gwangju, South Korea
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Gyeonggi-do, South Korea
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Incheon, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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A Coruña, Spain
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Granada, Spain
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Madrid, Spain
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Palma de Mallorca, Spain
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Salamanca, Spain
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Santa Cruz de Tenerife, Spain
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Santiago de Compostela, Spain
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Valencia, Spain
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Valladolid, Spain
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Skövde, Sweden
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Geneva, Switzerland
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Lausanne, Switzerland
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Zurich, Switzerland
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Birmingham, United Kingdom
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Leicester, United Kingdom
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Liverpool, United Kingdom
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Manchester, United Kingdom
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Middlesbrough, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2016
First Posted
November 21, 2016
Study Start
April 1, 2016
Primary Completion
October 15, 2021
Study Completion
October 15, 2021
Last Updated
August 22, 2022
Record last verified: 2022-08