Product Surveillance Registry

NCT ID: NCT01524276

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2040-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Rhythm Disorders Urological Disorders Neurological Disorders Cardiovascular Disorders Digestive Disorders Intracranial Aneurysm Mechanical Circulatory Support Respiratory Therapy Aortic, Peripheral Vascular and Venous Disorders Minimally Invasive Surgical Procedures Diagnostic Techniques and Procedures Surgical Procedures, Operative Renal Insufficiency Neurovascular Coronary Artery Disease Ear, Nose and Throat Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Birmingham, Alabama, United States

Site Status RECRUITING

Huntsville, Alabama, United States

Site Status RECRUITING

Chandler, Arizona, United States

Site Status RECRUITING

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

Site Status ACTIVE_NOT_RECRUITING

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

Site Status ACTIVE_NOT_RECRUITING

Jackson, Mississippi, United States

Site Status ACTIVE_NOT_RECRUITING

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

Site Status ACTIVE_NOT_RECRUITING

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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Poughkeepsie, New York, United States

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Riverhead, New York, United States

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Roslyn, New York, United States

Site Status ACTIVE_NOT_RECRUITING

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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Eatonton, 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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Winston-Salem, 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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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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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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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

Site Status ACTIVE_NOT_RECRUITING

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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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

Site Status ACTIVE_NOT_RECRUITING

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

Site Status ACTIVE_NOT_RECRUITING

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

Site Status ACTIVE_NOT_RECRUITING

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

Site Status ACTIVE_NOT_RECRUITING

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

Site Status ACTIVE_NOT_RECRUITING

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

Site Status ACTIVE_NOT_RECRUITING

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

Site Status ACTIVE_NOT_RECRUITING

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

Site Status ACTIVE_NOT_RECRUITING

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

Site Status ACTIVE_NOT_RECRUITING

Glasgow, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

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

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Southampton, , United Kingdom

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Countries

Review the countries where the study has at least one active or historical site.

Chile Iceland Jordan Kazakhstan Russia Slovenia South Africa Turkey (Türkiye) United Arab Emirates United States Argentina Australia Austria Belgium Brazil Canada China Colombia Czechia Denmark Finland France Germany Greece Hong Kong Hungary India Ireland Israel Italy Japan Kuwait Malaysia Mexico Netherlands New Zealand Norway Panama Poland Portugal Puerto Rico Saudi Arabia Serbia Slovakia South Korea Spain Sweden Switzerland Taiwan United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Medtronic Product Surveillance Registry

Role: CONTACT

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40758483 (View on PubMed)

Patel 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.

Reference Type DERIVED
PMID: 36579406 (View on PubMed)

Qin 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.

Reference Type DERIVED
PMID: 35925831 (View on PubMed)

Garg 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.

Reference Type DERIVED
PMID: 32763431 (View on PubMed)

Singh 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.

Reference Type DERIVED
PMID: 32009263 (View on PubMed)

Stearns 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.

Reference Type DERIVED
PMID: 31567325 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PSR

Identifier Type: -

Identifier Source: org_study_id