Product Surveillance Registry
PSR
Medtronic Product Surveillance Registry
1 other identifier
observational
100,000
39 countries
388
Brief Summary
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Longer than P75 for all trials
388 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
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 30, 2012
CompletedFirst Posted
Study publicly available on registry
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2040
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2040
May 20, 2026
December 1, 2025
28 years
January 30, 2012
May 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Effectiveness of Market Released products
Every 6-12 months (Therapy-dependent)
Eligibility Criteria
Subjects implanted with Medtronic qualifying therapy product.
You may qualify if:
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Patient has or is intended to receive or be treated with an eligible Medtronic product
- Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment
You may not qualify if:
- Patient who is, or will be, inaccessible for follow-up
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtroniclead
Study Sites (393)
Unknown Facility
Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Chandler, Arizona, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Aliso Viejo, California, United States
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Chula Vista, California, United States
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Colton, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Napa, 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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Stanford, California, United States
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Torrance, California, United States
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Ventura, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Lakewood, Colorado, United States
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Darien, Connecticut, United States
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Hartford, Connecticut, United States
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New Haven, Connecticut, 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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Davie, Florida, United States
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Jacksonville, Florida, United States
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Naples, 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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Sarasota, Florida, United States
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Tampa, Florida, United States
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Weston, Florida, United States
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Gainesville, Georgia, 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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Iowa City, Iowa, 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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New Orleans, Louisiana, 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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Boston, Massachusetts, United States
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Holyoke, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Bay City, Michigan, United States
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Lansing, Michigan, United States
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Rochester Hills, 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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Jackson, 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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Omaha, Nebraska, United States
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Lebanon, New Hampshire, United States
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Camden, New Jersey, United States
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Marlton, 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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Teaneck, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Bay Shore, 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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Mount Kisco, 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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Port Jefferson, New York, United States
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Poughkeepsie, New York, United States
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Riverhead, New York, United States
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Roslyn, New York, United States
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Staten Island, New York, United States
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Stony Brook, New York, United States
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Utica, New York, United States
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Chapel Hill, North Carolina, United States
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Charleston, North Carolina, United States
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Durham, North Carolina, United States
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Edenton, North Carolina, United States
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Pinehurst, North Carolina, United States
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Raleigh, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Mount Orab, Ohio, 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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Mechanicsburg, 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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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Orangeburg, South Carolina, United States
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Spartanburg, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Germantown, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Grapevine, Texas, United States
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Houston, Texas, United States
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Kyle, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Charlottesville, Virginia, United States
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Fairfax, Virginia, United States
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Falls Church, Virginia, United States
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Fredericksburg, Virginia, United States
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Bremerton, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Morgantown, West Virginia, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, Argentina
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Westmead, New South Wales, Australia
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Chermside, Australia
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Murdoch, Australia
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Southport, Australia
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Innsbruck, Austria
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Linz, Austria
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Genk, Belgium, Belgium
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Aalst, Belgium
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Bruges, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Roeselare, Belgium
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Sint-Niklaas, Belgium
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São Paulo, Brazil
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Calgary, Alberta, Canada
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Kingston, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Canada
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Toronto, Canada
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Chengdu, Sichuan, China
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Beijing, China
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Chengdu, China
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Dalian, China
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Guangzhou, China
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Hangzhou, China
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Harbin, China
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Kunming, China
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Nanchang, China
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Nanjing, China
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Shanghai, China
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Suzhou, China
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Cartagena, Colombia
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Medellín, Colombia
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Pereira, Colombia
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Rionegro, Colombia
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Prague, Czechia
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Copenhagen, Denmark
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Hellerup, Denmark
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Hillerød, Denmark
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Odense, Denmark
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Helsinki, Finland
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Tampere, Finland
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Avignon, France
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Bordeaux, France
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Boulogne-Billancourt, France
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Brest, France
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Caen, France
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Chambray, France
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Clermont-Ferrand, France
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Créteil, France
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Dijon, France
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La Rochelle, France
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La Tronche, France
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Lille, France
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Marseille, France
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Montpellier, France
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Nantes, France
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Ollioules, France
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Paris, France
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Pessac, France
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Pringy, France
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Rennes, France
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Saint-Priest-en-Jarez, France
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Strasbourg, France
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Toulouse, France
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Villeurbanne, France
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Aachen, Germany
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Arnsberg, Germany
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Bad Oeynhausen, Germany
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Berlin, Germany
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Berlin, Germany
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Bochum, Germany
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Bremen, Germany
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Cologne, Germany
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Düsseldorf, Germany
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Freiburg im Breisgau, Germany
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Hagen, Germany
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Halle, Germany
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Hamburg, Germany
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Hanover, Germany
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Heidelberg, Germany
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Jena, Germany
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Karlsruhe, Germany
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Leipzig, Germany
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Lübeck, Germany
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München, Germany
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Münster, Germany
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Stuttgart, Germany
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Tübingen, Germany
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Ulm, Germany
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Wiesbaden, Germany
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Athens, Greece
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Marousi, Greece
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Thessaloniki, Greece
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Hong Kong, Hong Kong
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Budapest, Hungary
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Jaipur, Rajasthan, India
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Hyderabad, Telangana, India
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Bangalore, India
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Bengaluru, India
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Chennai, India
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Gurgaon, India
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Kochi, India
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New Delhi, India
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Galway, Ireland
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Ashkelon, Israel
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Beersheba, Israel
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Jerusalem, Israel
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Ramat Gan, Israel
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Acquaviva delle Fonti, Italy
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Ancona, Italy
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Bari, Italy
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Bologna, Italy
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Brescia, Italy
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Caserta, Italy
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Castrovillari, Italy
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Cotignola, Italy
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Lecce, Italy
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Milan, Italy
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Modena, Italy
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Monza, Italy
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Palermo, Italy
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Pisa, Italy
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Roma, Italy
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Rome, Italy
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Taranto, Italy
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Udine, Italy
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Sakai, Osaka, Japan
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Ageo, Saitama, Japan
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Hidaka, Saitama, Japan
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Koshigaya, Saitama, Japan
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Tokyo, Tachikawa, Japan
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Bunkyō-Ku, Tokyo, Japan
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Minato-Ku, Tokyo, Japan
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Yonago, Tottori, Japan
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Chiba, Japan
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Fukui, Japan
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Fukuoka, Japan
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Gifu, Japan
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Hirosaki, Japan
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Hiroshima, Japan
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Kagoshima, Japan
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Kamakura, Japan
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Kawasaki, Japan
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Kitakyushu, Japan
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Kofu, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Mitaka, Japan
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Nagoya, Japan
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Niigata, Japan
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Okayama, Japan
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Ōsaka-sayama, Japan
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Sapporo, Japan
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Shinagawa-Ku, Japan
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Shizuoka, Japan
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Suita, Japan
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Tokyo, Japan
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Toyoake, Japan
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Urasoe, Japan
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Yokohama, Japan
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Kuwait City, Kuwait
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Kuala Lumpur, Malaysia
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Mexico City, Mexico
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Amsterdam, Netherlands
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Doetinchem, Netherlands
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Eindhoven, Netherlands
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Enschede, Netherlands
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Groningen, Netherlands
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Heerlen, Netherlands
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Hengelo, Netherlands
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Leiden, Netherlands
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Maastricht, Netherlands
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Nieuwegein, Netherlands
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Rotterdam, Netherlands
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The Hague, Netherlands
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Christchurch, New Zealand
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Bergen, Norway
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Lorenskog, Norway
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Trondheim, Norway
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Panama City, Panama
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Poznan, Poland
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Warsaw, Poland
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Zabrze, Poland
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Carnaxide, Portugal
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Creixomil, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Santarém, Portugal
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Aibonito, Puerto Rico
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Rio Piedras, Puerto Rico
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Jeddah, Saudi Arabia
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Riyadh, Saudi Arabia
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Belgrade, Serbia
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Bratislava, Slovakia
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Yangsan, Gyeongsangnam-do, South Korea
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Busan, South Korea
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Changwon, South Korea
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Cheongju-si, South Korea
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Daegu, South Korea
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Daejeon, 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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Jeonju, South Korea
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Seongnam-si, South Korea
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Seoul, South Korea
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Suwon, South Korea
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A Coruña, Spain
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Córdoba, Spain
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Elche, Spain
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Girona, Spain
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Granada, Spain
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L'Hospitalet de Llobregat, Spain
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Madrid, Spain
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Málaga, 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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Toledo, Spain
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Valencia, Spain
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Valladolid, Spain
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Vitoria-Gasteiz, Spain
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Gothenburg, Sweden
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Lund, Sweden
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Skövde, Sweden
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Basel, Switzerland
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Bern, Switzerland
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Fribourg, Switzerland
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Geneva, Switzerland
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Lausanne, Switzerland
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Lugano, Switzerland
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Morges, Switzerland
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Zurich, Switzerland
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Taichung, Taiwan
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Barnstaple, United Kingdom
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Birmingham, United Kingdom
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Blackpool, United Kingdom
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Bristol, United Kingdom
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Chelmsford, United Kingdom
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Glasgow, United Kingdom
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Harrow, United Kingdom
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Leeds, United Kingdom
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Leicester, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Middlesbrough, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Northampton, United Kingdom
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Sheffield, United Kingdom
Unknown Facility
Southampton, United Kingdom
Related Publications (6)
Goya M, Park SJ, Ando K, Holbrook R, Iskandar R, Jacobsen L, Mozingo JD, Joung B; SPARK Registry Investigators. Safety and efficacy of an intrinsic antitachycardia pacing algorithm in patients from Japan and South Korea: results from a cardiac device registry in the Asia Pacific region. J Med Econ. 2025 Dec;28(1):1307-1318. doi: 10.1080/13696998.2025.2543213. Epub 2025 Aug 13.
PMID: 40758483DERIVEDPatel D, Rao A, Friedman PA, Deshmukh AJ, Lande J, Murphy JA, Brown ML, Lexcen DR, Wilkoff BL. New atrial arrhythmia occurrence in single chamber implantable cardioverter defibrillator patients: A real-world investigation. J Cardiovasc Electrophysiol. 2023 Feb;34(2):438-444. doi: 10.1111/jce.15790. Epub 2022 Dec 30.
PMID: 36579406DERIVEDQin D, Filippaios A, Murphy J, Berg M, Lampert R, Schloss EJ, Noone M, Mela T. Short- and Long-Term Risk of Lead Dislodgement Events: Real-World Experience From Product Surveillance Registry. Circ Arrhythm Electrophysiol. 2022 Aug;15(8):e011029. doi: 10.1161/CIRCEP.122.011029. Epub 2022 Aug 4.
PMID: 35925831DERIVEDGarg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4.
PMID: 32763431DERIVEDSingh JP, Cha YM, Lunati M, Chung ES, Li S, Smeets P, O'Donnell D. Real-world behavior of CRT pacing using the AdaptivCRT algorithm on patient outcomes: Effect on mortality and atrial fibrillation incidence. J Cardiovasc Electrophysiol. 2020 Apr;31(4):825-833. doi: 10.1111/jce.14376. Epub 2020 Feb 28.
PMID: 32009263DERIVEDStearns LM, Abd-Elsayed A, Perruchoud C, Spencer R, Hammond K, Stromberg K, Weaver T. Intrathecal Drug Delivery Systems for Cancer Pain: An Analysis of a Prospective, Multicenter Product Surveillance Registry. Anesth Analg. 2020 Feb;130(2):289-297. doi: 10.1213/ANE.0000000000004425.
PMID: 31567325DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2012
First Posted
February 1, 2012
Study Start
January 1, 2012
Primary Completion (Estimated)
January 1, 2040
Study Completion (Estimated)
January 1, 2040
Last Updated
May 20, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share