- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01524276
Product Surveillance Registry (PSR)
March 25, 2024 updated by: Medtronic
Medtronic Product Surveillance Registry
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.
Study Overview
Status
Recruiting
Conditions
- Coronary Artery Disease
- Renal Insufficiency
- Neurological Disorders
- Intracranial Aneurysm
- Surgical Procedures, Operative
- Respiratory Therapy
- Minimally Invasive Surgical Procedures
- Cardiac Rhythm Disorders
- Urological Disorders
- Cardiovascular Disorders
- Digestive Disorders
- Mechanical Circulatory Support
- Aortic, Peripheral Vascular and Venous Disorders
- Diagnostic Techniques and Procedures
- Neurovascular
- Ear, Nose and Throat Disorder
Study Type
Observational
Enrollment (Estimated)
100000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Medtronic Product Surveillance Registry
- Email: rs.productsurveillanceregistry@medtronic.com
Study Locations
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Buenos Aires, Argentina
- Recruiting
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Chermside, Australia
- Recruiting
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Murdoch, Australia
- Recruiting
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Southport, Australia
- Recruiting
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New South Wales
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Westmead, New South Wales, Australia
- Recruiting
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Linz, Austria
- Recruiting
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Aalst, Belgium
- Recruiting
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Brugge, Belgium
- Recruiting
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Brussel, Belgium
- Recruiting
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Edegem, Belgium
- Recruiting
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Gent, Belgium
- Recruiting
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Leuven, Belgium
- Recruiting
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Liege, Belgium
- Recruiting
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Roeselare, Belgium
- Recruiting
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São Paulo, Brazil
- Recruiting
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Quebec, Canada
- Recruiting
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Quebec City, Canada
- Recruiting
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Toronto, Canada
- Recruiting
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Alberta
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Calgary, Alberta, Canada
- Recruiting
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Ontario
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Kingston, Ontario, Canada
- Recruiting
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Quebec
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Montreal, Quebec, Canada
- Recruiting
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Beijing, China
- Recruiting
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Changsha, China
- Recruiting
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Dalian, China
- Recruiting
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Fuzhou, China
- Recruiting
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Harbin, China
- Recruiting
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Kunming, China
- Recruiting
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Nanchang, China
- Recruiting
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Shanghai, China
- Recruiting
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Shantou, China
- Recruiting
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Suzhou, China
- Recruiting
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Taiyuan, China
- Recruiting
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Tianjin, China
- Recruiting
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Sichuan
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Chengdu, Sichuan, China
- Recruiting
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Cartagena, Colombia
- Recruiting
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Medellin, Colombia
- Recruiting
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Pereira, Colombia
- Recruiting
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Rionegro, Colombia
- Recruiting
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Praha, Czechia
- Recruiting
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Hellerup, Denmark
- Recruiting
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Hillerød, Denmark
- Recruiting
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Kobenhavn, Denmark
- Recruiting
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Odense, Denmark
- Recruiting
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Helsinki, Finland
- Recruiting
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Tampere, Finland
- Recruiting
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Avignon, France
- Recruiting
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Bayonne, France
- Recruiting
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Bordeaux, France
- Recruiting
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Boulogne-Billancourt, France
- Recruiting
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Brest Cedex, France
- Recruiting
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Caen, France
- Recruiting
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Chambray, France
- Recruiting
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Clermont Ferrand, France
- Recruiting
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Créteil, France
- Recruiting
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Dijon, France
- Recruiting
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La Rochelle, France
- Recruiting
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La Tronche, France
- Recruiting
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Lille Cedex, France
- Recruiting
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Marseille Cedex 5, France
- Recruiting
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Montpellier Cedex 5, France
- Recruiting
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Nantes, France
- Recruiting
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Neuilly-sur-Seine, France
- Recruiting
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Ollioules, France
- Active, not recruiting
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Paris, France
- Recruiting
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Pringy, France
- Recruiting
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Rennes, France
- Recruiting
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Saint-Priest-en-Jarez, France
- Recruiting
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Strasbourg, France
- Recruiting
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Villeurbanne, France
- Recruiting
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Aachen, Germany
- Recruiting
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Bad Oeynhausen, Germany
- Recruiting
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Bremen, Germany
- Recruiting
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Düsseldorf, Germany
- Recruiting
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Essen, Germany
- Recruiting
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Frankfurt am main, Germany
- Recruiting
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Freiburg, Germany
- Recruiting
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Hagen, Germany
- Recruiting
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Hamburg, Germany
- Recruiting
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Hannover, Germany
- Recruiting
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Homburg, Germany
- Recruiting
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Jena, Germany
- Recruiting
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Karlsruhe, Germany
- Recruiting
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Köln, Germany
- Recruiting
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Leipzig, Germany
- Recruiting
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Lübeck, Germany
- Recruiting
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Munster, Germany
- Recruiting
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München, Germany
- Recruiting
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Ulm, Germany
- Recruiting
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Wiesbaden, Germany
- Recruiting
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Athens, Greece
- Recruiting
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Maroúsi, Greece
- Recruiting
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Thessaloníki, Greece
- Recruiting
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Hong Kong, Hong Kong
- Recruiting
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Budapest, Hungary
- Recruiting
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Chennai, India
- Recruiting
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New Delhi, India
- Recruiting
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Telangana
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Hyderabad, Telangana, India
- Recruiting
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Galway, Ireland
- Recruiting
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Jerusalem, Israel
- Recruiting
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Ramat Gan, Israel
- Recruiting
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Acquaviva Delle Fonti, Italy
- Recruiting
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Ancona, Italy
- Recruiting
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Bassano Del Grappa, Italy
- Recruiting
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Bologna, Italy
- Recruiting
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Brescia, Italy
- Recruiting
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Castrovillari, Italy
- Recruiting
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Lecce, Italy
- Recruiting
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Milano, Italy
- Not yet recruiting
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Palermo, Italy
- Recruiting
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Pavia, Italy
- Recruiting
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Roma, Italy
- Recruiting
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Rome, Italy
- Recruiting
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Taranto, Italy
- Recruiting
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Udine, Italy
- Recruiting
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Vimercate, Italy
- Recruiting
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Chiba, Japan
- Recruiting
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Fukuoka, Japan
- Recruiting
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Gifu, Japan
- Recruiting
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Hirosaki, Japan
- Recruiting
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Hiroshima, Japan
- Recruiting
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Hiroshima City, Japan
- Recruiting
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Kagoshima, Japan
- Recruiting
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Kamakura, Japan
- Recruiting
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Kawasaki, Japan
- Recruiting
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Kitakyushu, Japan
- Recruiting
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Kumamoto, Japan
- Recruiting
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Kyoto, Japan
- Recruiting
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Mitaka, Japan
- Recruiting
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Nagoya, Japan
- Recruiting
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Niigata, Japan
- Recruiting
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Okayama, Japan
- Recruiting
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Sapporo, Japan
- Recruiting
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Shinagawa-Ku, Japan
- Recruiting
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Shizuoka, Japan
- Recruiting
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Suita, Japan
- Recruiting
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Toyoake, Japan
- Recruiting
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Urasoe, Japan
- Recruiting
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Yokohama, Japan
- Recruiting
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Ōsaka-sayama, Japan
- Recruiting
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Osaka
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Sakai, Osaka, Japan
- Recruiting
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Saitama
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Ageo, Saitama, Japan
- Recruiting
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Hidaka, Saitama, Japan
- Recruiting
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Koshigaya, Saitama, Japan
- Recruiting
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Tachikawa
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Tokyo, Tachikawa, Japan
- Recruiting
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Tokyo
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Bunkyō-Ku, Tokyo, Japan
- Recruiting
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Minato-Ku, Tokyo, Japan
- Recruiting
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Tottori
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Yonago, Tottori, Japan
- Recruiting
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Busan, Korea, Republic of
- Recruiting
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Changwon, Korea, Republic of
- Recruiting
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Cheongju-si, Korea, Republic of
- Recruiting
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Daegu, Korea, Republic of
- Recruiting
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Daejeon, Korea, Republic of
- Recruiting
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Gangneung, Korea, Republic of
- Recruiting
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Gwangju, Korea, Republic of
- Recruiting
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Gyeonggi-do, Korea, Republic of
- Recruiting
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Incheon, Korea, Republic of
- Recruiting
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Jeonju, Korea, Republic of
- Recruiting
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Seongnam-si, Korea, Republic of
- Recruiting
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Seoul, Korea, Republic of
- Recruiting
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Suwon-si, Korea, Republic of
- Recruiting
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Gyeongsangnam-do
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Yangsan, Gyeongsangnam-do, Korea, Republic of
- Recruiting
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Kuwait, Kuwait
- Recruiting
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Kuala Lumpur, Malaysia
- Recruiting
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Ciudad de mexico, Mexico
- Recruiting
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Eindhoven, Netherlands
- Recruiting
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Enschede, Netherlands
- Recruiting
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Groningen, Netherlands
- Recruiting
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Heerlen, Netherlands
- Recruiting
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Hengelo, Netherlands
- Recruiting
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Leiden, Netherlands
- Recruiting
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Maastricht, Netherlands
- Recruiting
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Nieuwegein, Netherlands
- Recruiting
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Rotterdam, Netherlands
- Recruiting
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Christchurch, New Zealand
- Recruiting
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Bergen, Norway
- Recruiting
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Oslo, Norway
- Recruiting
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Trondheim, Norway
- Recruiting
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Poznań, Poland
- Recruiting
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Warszawa, Poland
- Recruiting
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Zabrze, Poland
- Recruiting
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Creixomil, Portugal
- Recruiting
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Lisboa, Portugal
- Recruiting
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Porto, Portugal
- Recruiting
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Santarém, Portugal
- Recruiting
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Aibonito, Puerto Rico
- Recruiting
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Rio Piedras, Puerto Rico
- Recruiting
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Belgrade, Serbia
- Recruiting
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Bratislava, Slovakia
- Recruiting
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A Coruña, Spain
- Recruiting
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Barcelona, Spain
- Recruiting
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Córdoba, Spain
- Recruiting
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Girona, Spain
- Recruiting
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Granada, Spain
- Recruiting
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L'Hospitalet De Llobregat, Spain
- Recruiting
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Madrid, Spain
- Recruiting
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Málaga, Spain
- Recruiting
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Palma De Mallorca, Spain
- Recruiting
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Salamanca, Spain
- Recruiting
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Santa Cruz De Tenerife, Spain
- Recruiting
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Santiago De Compostela, Spain
- Recruiting
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Toledo, Spain
- Recruiting
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Valencia, Spain
- Recruiting
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Valladolid, Spain
- Recruiting
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Göteborg, Sweden
- Recruiting
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Lund, Sweden
- Recruiting
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Skövde, Sweden
- Recruiting
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Basel, Switzerland
- Recruiting
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Bern, Switzerland
- Recruiting
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Fribourg, Switzerland
- Recruiting
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Geneve, Switzerland
- Recruiting
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Lausanne, Switzerland
- Recruiting
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Lugano, Switzerland
- Recruiting
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Morges, Switzerland
- Recruiting
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Zürich, Switzerland
- Recruiting
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Barnstaple, United Kingdom
- Recruiting
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Birmingham, United Kingdom
- Recruiting
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Blackpool, United Kingdom
- Recruiting
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Bristol, United Kingdom
- Recruiting
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Leeds, United Kingdom
- Recruiting
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Leicester, United Kingdom
- Recruiting
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Liverpool, United Kingdom
- Recruiting
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London, United Kingdom
- Recruiting
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Manchester, United Kingdom
- Recruiting
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Middlesbrough, United Kingdom
- Recruiting
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Newcastle Upon Tyne, United Kingdom
- Recruiting
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Northampton, United Kingdom
- Recruiting
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Nottingham, United Kingdom
- Recruiting
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Sheffield, United Kingdom
- Recruiting
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Alabama
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Birmingham, Alabama, United States
- Recruiting
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Huntsville, Alabama, United States
- Recruiting
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Alaska
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Anchorage, Alaska, United States
- Recruiting
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Arizona
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Chandler, Arizona, United States
- Recruiting
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Phoenix, Arizona, United States
- Recruiting
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Arkansas
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Jonesboro, Arkansas, United States
- Recruiting
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Little Rock, Arkansas, United States
- Recruiting
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California
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Aliso Viejo, California, United States
- Recruiting
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Bakersfield, California, United States
- Recruiting
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Carlsbad, California, United States
- Recruiting
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Chula Vista, California, United States
- Recruiting
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Colton, California, United States
- Recruiting
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Los Angeles, California, United States
- Recruiting
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Napa, California, United States
- Recruiting
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Rancho Mirage, California, United States
- Recruiting
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Redwood City, California, United States
- Recruiting
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Salinas, California, United States
- Recruiting
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San Diego, California, United States
- Recruiting
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Stanford, California, United States
- Recruiting
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Torrance, California, United States
- Recruiting
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Van Nuys, California, United States
- Recruiting
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Ventura, California, United States
- Recruiting
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Colorado
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Aurora, Colorado, United States
- Recruiting
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Colorado Springs, Colorado, United States
- Recruiting
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Lakewood, Colorado, United States
- Recruiting
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Connecticut
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Hartford, Connecticut, United States
- Recruiting
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New Haven, Connecticut, United States
- Recruiting
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District of Columbia
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Washington, District of Columbia, United States
- Recruiting
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Florida
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Bradenton, Florida, United States
- Recruiting
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Clearwater, Florida, United States
- Recruiting
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Davie, Florida, United States
- Recruiting
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Jacksonville, Florida, United States
- Recruiting
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Naples, Florida, United States
- Recruiting
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Panama City, Florida, United States
- Recruiting
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Safety Harbor, Florida, United States
- Recruiting
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Sarasota, Florida, United States
- Recruiting
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Weston, Florida, United States
- Recruiting
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Georgia
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Gainesville, Georgia, United States
- Active, not recruiting
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Illinois
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Chicago, Illinois, United States
- Recruiting
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Indiana
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Evansville, Indiana, United States
- Recruiting
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Indianapolis, Indiana, United States
- Recruiting
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Iowa
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Iowa City, Iowa, United States
- Recruiting
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West Des Moines, Iowa, United States
- Recruiting
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Kansas
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Kansas City, Kansas, United States
- Recruiting
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Kentucky
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Edgewood, Kentucky, United States
- Recruiting
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Louisville, Kentucky, United States
- Recruiting
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Louisiana
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Baton Rouge, Louisiana, United States
- Recruiting
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New Orleans, Louisiana, United States
- Recruiting
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Maryland
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Clinton, Maryland, United States
- Recruiting
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Hyattsville, Maryland, United States
- Recruiting
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Salisbury, Maryland, United States
- Recruiting
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Silver Spring, Maryland, United States
- Recruiting
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Massachusetts
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Boston, Massachusetts, United States
- Recruiting
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Holyoke, Massachusetts, United States
- Recruiting
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Michigan
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Ann Arbor, Michigan, United States
- Recruiting
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Lansing, Michigan, United States
- Recruiting
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Rochester Hills, Michigan, United States
- Recruiting
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Ypsilanti, Michigan, United States
- Recruiting
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Minnesota
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Coon Rapids, Minnesota, United States
- Recruiting
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Minneapolis, Minnesota, United States
- Recruiting
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Robbinsdale, Minnesota, United States
- Recruiting
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Rochester, Minnesota, United States
- Recruiting
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Saint Cloud, Minnesota, United States
- Active, not recruiting
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Mississippi
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Jackson, Mississippi, United States
- Active, not recruiting
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Missouri
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Columbia, Missouri, United States
- Recruiting
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Kansas City, Missouri, United States
- Recruiting
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Saint Louis, Missouri, United States
- Recruiting
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Nebraska
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Omaha, Nebraska, United States
- Recruiting
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New Hampshire
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Lebanon, New Hampshire, United States
- Active, not recruiting
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New Jersey
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Camden, New Jersey, United States
- Recruiting
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Marlton, New Jersey, United States
- Recruiting
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Morristown, New Jersey, United States
- Recruiting
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Ocean Township, New Jersey, United States
- Recruiting
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Teaneck, New Jersey, United States
- Recruiting
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New Mexico
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Albuquerque, New Mexico, United States
- Recruiting
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New York
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Albany, New York, United States
- Recruiting
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Bay Shore, New York, United States
- Recruiting
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Huntington, New York, United States
- Recruiting
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Manhasset, New York, United States
- Recruiting
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Mount Kisco, New York, United States
- Recruiting
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New Hyde Park, New York, United States
- Recruiting
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New York, New York, United States
- Recruiting
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Poughkeepsie, New York, United States
- Recruiting
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Riverhead, New York, United States
- Recruiting
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Roslyn, New York, United States
- Active, not recruiting
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Staten Island, New York, United States
- Recruiting
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Stony Brook, New York, United States
- Recruiting
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Utica, New York, United States
- Recruiting
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North Carolina
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Chapel Hill, North Carolina, United States
- Recruiting
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Durham, North Carolina, United States
- Recruiting
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Pinehurst, North Carolina, United States
- Recruiting
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Raleigh, North Carolina, United States
- Recruiting
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Winston-Salem, North Carolina, United States
- Recruiting
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Ohio
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Akron, Ohio, United States
- Recruiting
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Cincinnati, Ohio, United States
- Recruiting
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Cleveland, Ohio, United States
- Recruiting
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Columbus, Ohio, United States
- Recruiting
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Dayton, Ohio, United States
- Recruiting
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Mount Orab, Ohio, United States
- Recruiting
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Oregon
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Portland, Oregon, United States
- Recruiting
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Pennsylvania
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Allentown, Pennsylvania, United States
- Recruiting
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Bethlehem, Pennsylvania, United States
- Recruiting
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Danville, Pennsylvania, United States
- Recruiting
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Erie, Pennsylvania, United States
- Recruiting
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Lancaster, Pennsylvania, United States
- Recruiting
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Mechanicsburg, Pennsylvania, United States
- Recruiting
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Pittsburgh, Pennsylvania, United States
- Recruiting
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Wilkes-Barre, Pennsylvania, United States
- Recruiting
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South Carolina
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Charleston, South Carolina, United States
- Recruiting
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Columbia, South Carolina, United States
- Recruiting
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Orangeburg, South Carolina, United States
- Recruiting
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Spartanburg, South Carolina, United States
- Recruiting
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South Dakota
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Sioux Falls, South Dakota, United States
- Recruiting
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Tennessee
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Germantown, Tennessee, United States
- Recruiting
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Memphis, Tennessee, United States
- Recruiting
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Nashville, Tennessee, United States
- Recruiting
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Texas
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Austin, Texas, United States
- Recruiting
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Dallas, Texas, United States
- Recruiting
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Fort Worth, Texas, United States
- Recruiting
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Houston, Texas, United States
- Recruiting
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Plano, Texas, United States
- Recruiting
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San Antonio, Texas, United States
- Recruiting
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The Woodlands, Texas, United States
- Recruiting
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Tyler, Texas, United States
- Recruiting
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Utah
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Salt Lake City, Utah, United States
- Recruiting
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Vermont
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Burlington, Vermont, United States
- Recruiting
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Virginia
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Charlottesville, Virginia, United States
- Recruiting
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Fairfax, Virginia, United States
- Recruiting
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Fredericksburg, Virginia, United States
- Recruiting
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Washington
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Bremerton, Washington, United States
- Recruiting
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Seattle, Washington, United States
- Recruiting
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Spokane, Washington, United States
- Recruiting
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West Virginia
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Morgantown, West Virginia, United States
- Recruiting
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Wisconsin
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Madison, Wisconsin, United States
- Recruiting
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Milwaukee, Wisconsin, United States
- Recruiting
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Subjects implanted with Medtronic qualifying therapy product.
Description
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 with exclusion criteria required by local law
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and Effectiveness of Market Released products
Time Frame: Every 6-12 months (Therapy-dependent)
|
Every 6-12 months (Therapy-dependent)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
January 1, 2030
Study Registration Dates
First Submitted
January 30, 2012
First Submitted That Met QC Criteria
January 30, 2012
First Posted (Estimated)
February 1, 2012
Study Record Updates
Last Update Posted (Actual)
March 27, 2024
Last Update Submitted That Met QC Criteria
March 25, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Kidney Diseases
- Coronary Disease
- Intracranial Arterial Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Coronary Artery Disease
- Cardiovascular Diseases
- Renal Insufficiency
- Nervous System Diseases
- Arrhythmias, Cardiac
- Digestive System Diseases
- Aneurysm
- Intracranial Aneurysm
- Urologic Diseases
Other Study ID Numbers
- PSR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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