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.
Conditions:
🦠 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
πŸ—“οΈ Study Start (Actual) January 2012
πŸ—“οΈ Primary Completion (Estimated) January 2030
βœ… Study Completion (Estimated) January 2030
πŸ‘₯ Enrollment (Estimated) 100000
πŸ”¬ Study Type OBSERVATIONAL
πŸ“Š Phase N/A
Locations:
πŸ“ Birmingham, Alabama, United States
πŸ“ Huntsville, Alabama, United States
πŸ“ Anchorage, Alaska, United States
πŸ“ Chandler, Arizona, United States
πŸ“ Phoenix, Arizona, United States
πŸ“ Jonesboro, Arkansas, United States
πŸ“ Little Rock, Arkansas, United States
πŸ“ Aliso Viejo, California, United States
πŸ“ Carlsbad, California, United States
πŸ“ Chula Vista, California, United States
πŸ“ Colton, California, United States
πŸ“ Los Angeles, California, United States
πŸ“ Napa, California, United States
πŸ“ Rancho Mirage, California, United States
πŸ“ Redwood City, California, United States
πŸ“ Salinas, California, United States
πŸ“ San Diego, California, United States
πŸ“ Stanford, California, United States
πŸ“ Torrance, California, United States
πŸ“ Van Nuys, California, United States
πŸ“ Ventura, California, United States
πŸ“ Aurora, Colorado, United States
πŸ“ Colorado Springs, Colorado, United States
πŸ“ Lakewood, Colorado, United States
πŸ“ Hartford, Connecticut, United States
πŸ“ New Haven, Connecticut, United States
πŸ“ Washington, District of Columbia, United States
πŸ“ Bradenton, Florida, United States
πŸ“ Clearwater, Florida, United States
πŸ“ Davie, Florida, United States
πŸ“ Jacksonville, Florida, United States
πŸ“ Naples, Florida, United States
πŸ“ Panama City, Florida, United States
πŸ“ Safety Harbor, Florida, United States
πŸ“ Sarasota, Florida, United States
πŸ“ Weston, Florida, United States
πŸ“ Gainesville, Georgia, United States
πŸ“ Chicago, Illinois, United States
πŸ“ Evansville, Indiana, United States
πŸ“ Indianapolis, Indiana, United States
πŸ“ Iowa City, Iowa, United States
πŸ“ West Des Moines, Iowa, United States
πŸ“ Kansas City, Kansas, United States
πŸ“ Edgewood, Kentucky, United States
πŸ“ Louisville, Kentucky, United States
πŸ“ New Orleans, Louisiana, United States
πŸ“ Hyattsville, Maryland, United States
πŸ“ Salisbury, Maryland, United States
πŸ“ Silver Spring, Maryland, United States
πŸ“ Boston, Massachusetts, United States
πŸ“ Holyoke, Massachusetts, United States
πŸ“ Ann Arbor, Michigan, United States
πŸ“ Lansing, Michigan, United States
πŸ“ Rochester Hills, Michigan, United States
πŸ“ Ypsilanti, Michigan, United States
πŸ“ Coon Rapids, Minnesota, United States
πŸ“ Minneapolis, Minnesota, United States
πŸ“ Robbinsdale, Minnesota, United States
πŸ“ Rochester, Minnesota, United States
πŸ“ Saint Cloud, Minnesota, United States
πŸ“ Jackson, Mississippi, United States
πŸ“ Columbia, Missouri, United States
πŸ“ Kansas City, Missouri, United States
πŸ“ Saint Louis, Missouri, United States
πŸ“ Omaha, Nebraska, United States
πŸ“ Lebanon, New Hampshire, United States
πŸ“ Camden, New Jersey, United States
πŸ“ Marlton, New Jersey, United States
πŸ“ Morristown, New Jersey, United States
πŸ“ Ocean Township, New Jersey, United States
πŸ“ Teaneck, New Jersey, United States
πŸ“ Albuquerque, New Mexico, United States
πŸ“ Albany, New York, United States
πŸ“ Bay Shore, New York, United States
πŸ“ Huntington, New York, United States
πŸ“ Manhasset, New York, United States
πŸ“ Mount Kisco, New York, United States
πŸ“ New Hyde Park, New York, United States
πŸ“ New York, New York, United States
πŸ“ Poughkeepsie, New York, United States
πŸ“ Riverhead, New York, United States
πŸ“ Roslyn, New York, United States
πŸ“ Staten Island, New York, United States
πŸ“ Stony Brook, New York, United States
πŸ“ Utica, New York, United States
πŸ“ Chapel Hill, North Carolina, United States
πŸ“ Durham, North Carolina, United States
πŸ“ Pinehurst, North Carolina, United States
πŸ“ Raleigh, North Carolina, United States
πŸ“ Winston-Salem, North Carolina, United States
πŸ“ Akron, Ohio, United States
πŸ“ Cincinnati, Ohio, United States
πŸ“ Cleveland, Ohio, United States
πŸ“ Columbus, Ohio, United States
πŸ“ Dayton, Ohio, United States
πŸ“ Mount Orab, Ohio, United States
πŸ“ Portland, Oregon, United States
πŸ“ Allentown, Pennsylvania, United States
πŸ“ Bethlehem, Pennsylvania, United States
πŸ“ Danville, Pennsylvania, United States
πŸ“ Erie, Pennsylvania, United States
πŸ“ Lancaster, Pennsylvania, United States
πŸ“ Mechanicsburg, Pennsylvania, United States
πŸ“ Pittsburgh, Pennsylvania, United States
πŸ“ Wilkes-Barre, Pennsylvania, United States
πŸ“ Charleston, South Carolina, United States
πŸ“ Columbia, South Carolina, United States
πŸ“ Orangeburg, South Carolina, United States
πŸ“ Spartanburg, South Carolina, United States
πŸ“ Sioux Falls, South Dakota, United States
πŸ“ Germantown, Tennessee, United States
πŸ“ Memphis, Tennessee, United States
πŸ“ Nashville, Tennessee, United States
πŸ“ Austin, Texas, United States
πŸ“ Dallas, Texas, United States
πŸ“ Fort Worth, Texas, United States
πŸ“ Houston, Texas, United States
πŸ“ Plano, Texas, United States
πŸ“ San Antonio, Texas, United States
πŸ“ Tyler, Texas, United States
πŸ“ Salt Lake City, Utah, United States
πŸ“ Burlington, Vermont, United States
πŸ“ Charlottesville, Virginia, United States
πŸ“ Fairfax, Virginia, United States
πŸ“ Fredericksburg, Virginia, United States
πŸ“ Bremerton, Washington, United States
πŸ“ Seattle, Washington, United States
πŸ“ Spokane, Washington, United States
πŸ“ Morgantown, West Virginia, United States
πŸ“ Madison, Wisconsin, United States
πŸ“ Milwaukee, Wisconsin, United States
πŸ“ Buenos Aires, Argentina
πŸ“ Westmead, New South Wales, Australia
πŸ“ Chermside, Australia
πŸ“ Murdoch, Australia
πŸ“ Southport, Australia
πŸ“ Innsbruck, Austria
πŸ“ Linz, Austria
πŸ“ Aalst, Belgium
πŸ“ Brugge, Belgium
πŸ“ Brussel, Belgium
πŸ“ Edegem, Belgium
πŸ“ Gent, Belgium
πŸ“ Leuven, Belgium
πŸ“ Liege, Belgium
πŸ“ Roeselare, Belgium
πŸ“ SΓ£o Paulo, Brazil
πŸ“ Calgary, Alberta, Canada
πŸ“ Kingston, Ontario, Canada
πŸ“ Montreal, Quebec, Canada
πŸ“ Quebec City, Canada
πŸ“ Quebec, Canada
πŸ“ Toronto, Canada
πŸ“ Chengdu, Sichuan, China
πŸ“ Beijing, China
πŸ“ Changsha, China
πŸ“ Dalian, China
πŸ“ Fuzhou, China
πŸ“ Guangzhou, China
πŸ“ Hangzhou, China
πŸ“ Harbin, China
πŸ“ Kunming, China
πŸ“ Nanchang, China
πŸ“ Shanghai, China
πŸ“ Shantou, China
πŸ“ Suzhou, China
πŸ“ Taiyuan, China
πŸ“ Tianjin, China
πŸ“ Cartagena, Colombia
πŸ“ Medellin, Colombia
πŸ“ Pereira, Colombia
πŸ“ Rionegro, Colombia
πŸ“ Praha, Czechia
πŸ“ Hellerup, Denmark
πŸ“ HillerΓΈd, Denmark
πŸ“ Kobenhavn, Denmark
πŸ“ Odense, Denmark
πŸ“ Helsinki, Finland
πŸ“ Tampere, Finland
πŸ“ Avignon, France
πŸ“ Bayonne, France
πŸ“ Bordeaux, France
πŸ“ Boulogne-Billancourt, France
πŸ“ Brest Cedex, France
πŸ“ Caen, France
πŸ“ Chambray, France
πŸ“ Clermont Ferrand, France
πŸ“ CrΓ©teil, France
πŸ“ Dijon, France
πŸ“ La Rochelle, France
πŸ“ La Tronche, France
πŸ“ Lille Cedex, France
πŸ“ Marseille Cedex 5, France
πŸ“ Montpellier Cedex 5, France
πŸ“ Nantes, France
πŸ“ Neuilly-sur-Seine, France
πŸ“ Ollioules, France
πŸ“ Paris, France
πŸ“ Pringy, France
πŸ“ Rennes, France
πŸ“ Saint-Priest-en-Jarez, France
πŸ“ Strasbourg, France
πŸ“ Villeurbanne, France
πŸ“ Aachen, Germany
πŸ“ Bad Oeynhausen, Germany
πŸ“ Bremen, Germany
πŸ“ DΓΌsseldorf, Germany
πŸ“ Essen, Germany
πŸ“ Frankfurt am main, Germany
πŸ“ Freiburg, Germany
πŸ“ Hagen, Germany
πŸ“ Hamburg, Germany
πŸ“ Hannover, Germany
πŸ“ Jena, Germany
πŸ“ Karlsruhe, Germany
πŸ“ KΓΆln, Germany
πŸ“ Leipzig, Germany
πŸ“ LΓΌbeck, Germany
πŸ“ Munster, Germany
πŸ“ MΓΌnchen, Germany
πŸ“ Ulm, Germany
πŸ“ Wiesbaden, Germany
πŸ“ Athens, Greece
πŸ“ MaroΓΊsi, Greece
πŸ“ ThessalonΓ­ki, Greece
πŸ“ Hong Kong, Hong Kong
πŸ“ Budapest, Hungary
πŸ“ Hyderabad, Telangana, India
πŸ“ Chennai, India
πŸ“ New Delhi, India
πŸ“ Galway, Ireland
πŸ“ Jerusalem, Israel
πŸ“ Ramat Gan, Israel
πŸ“ Acquaviva Delle Fonti, Italy
πŸ“ Ancona, Italy
πŸ“ Bassano Del Grappa, Italy
πŸ“ Bologna, Italy
πŸ“ Brescia, Italy
πŸ“ Castrovillari, Italy
πŸ“ Chieri, Italy
πŸ“ Lecce, Italy
πŸ“ Milano, Italy
πŸ“ Palermo, Italy
πŸ“ Pavia, Italy
πŸ“ Roma, Italy
πŸ“ Rome, Italy
πŸ“ Taranto, Italy
πŸ“ Udine, Italy
πŸ“ Vimercate, Italy
πŸ“ Sakai, Osaka, Japan
πŸ“ Ageo, Saitama, Japan
πŸ“ Hidaka, Saitama, Japan
πŸ“ Koshigaya, Saitama, Japan
πŸ“ Tokyo, Tachikawa, Japan
πŸ“ Bunkyō-Ku, Tokyo, Japan
πŸ“ Minato-Ku, Tokyo, Japan
πŸ“ Yonago, Tottori, Japan
πŸ“ Chiba, Japan
πŸ“ Fukuoka, Japan
πŸ“ Gifu, Japan
πŸ“ Hirosaki, Japan
πŸ“ Hiroshima City, Japan
πŸ“ Hiroshima, Japan
πŸ“ Kagoshima, Japan
πŸ“ Kamakura, Japan
πŸ“ Kawasaki, Japan
πŸ“ Kitakyushu, Japan
πŸ“ Kumamoto, Japan
πŸ“ Kyoto, Japan
πŸ“ Mitaka, Japan
πŸ“ Nagoya, Japan
πŸ“ Niigata, Japan
πŸ“ Okayama, Japan
πŸ“ Sapporo, Japan
πŸ“ Shinagawa-Ku, Japan
πŸ“ Shizuoka, Japan
πŸ“ Suita, Japan
πŸ“ Toyoake, Japan
πŸ“ Urasoe, Japan
πŸ“ Yokohama, Japan
πŸ“ Ōsaka-sayama, Japan
πŸ“ Yangsan, Gyeongsangnam-do, Korea, Republic of
πŸ“ Busan, Korea, Republic of
πŸ“ Changwon, Korea, Republic of
πŸ“ Cheongju-si, Korea, Republic of
πŸ“ Daegu, Korea, Republic of
πŸ“ Daejeon, Korea, Republic of
πŸ“ Gangneung, Korea, Republic of
πŸ“ Gwangju, Korea, Republic of
πŸ“ Gyeonggi-do, Korea, Republic of
πŸ“ Incheon, Korea, Republic of
πŸ“ Jeonju, Korea, Republic of
πŸ“ Seongnam-si, Korea, Republic of
πŸ“ Seoul, Korea, Republic of
πŸ“ Suwon-si, Korea, Republic of
πŸ“ Kuwait, Kuwait
πŸ“ Kuala Lumpur, Malaysia
πŸ“ Ciudad de mexico, Mexico
πŸ“ Eindhoven, Netherlands
πŸ“ Enschede, Netherlands
πŸ“ Groningen, Netherlands
πŸ“ Heerlen, Netherlands
πŸ“ Hengelo, Netherlands
πŸ“ Leiden, Netherlands
πŸ“ Maastricht, Netherlands
πŸ“ Nieuwegein, Netherlands
πŸ“ Rotterdam, Netherlands
πŸ“ Christchurch, New Zealand
πŸ“ Bergen, Norway
πŸ“ Oslo, Norway
πŸ“ Trondheim, Norway
πŸ“ PoznaΕ„, Poland
πŸ“ Warszawa, Poland
πŸ“ Zabrze, Poland
πŸ“ Creixomil, Portugal
πŸ“ Lisboa, Portugal
πŸ“ Porto, Portugal
πŸ“ SantarΓ©m, Portugal
πŸ“ Aibonito, Puerto Rico
πŸ“ Rio Piedras, Puerto Rico
πŸ“ Jeddah, Saudi Arabia
πŸ“ Belgrade, Serbia
πŸ“ Bratislava, Slovakia
πŸ“ A CoruΓ±a, Spain
πŸ“ Barcelona, Spain
πŸ“ CΓ³rdoba, Spain
πŸ“ Girona, Spain
πŸ“ Granada, Spain
πŸ“ L'Hospitalet De Llobregat, Spain
πŸ“ Madrid, Spain
πŸ“ MΓ‘laga, Spain
πŸ“ Palma De Mallorca, Spain
πŸ“ Salamanca, Spain
πŸ“ Santa Cruz De Tenerife, Spain
πŸ“ Santiago De Compostela, Spain
πŸ“ Toledo, Spain
πŸ“ Valencia, Spain
πŸ“ Valladolid, Spain
πŸ“ GΓΆteborg, Sweden
πŸ“ Lund, Sweden
πŸ“ SkΓΆvde, Sweden
πŸ“ Basel, Switzerland
πŸ“ Bern, Switzerland
πŸ“ Fribourg, Switzerland
πŸ“ Geneve, Switzerland
πŸ“ Lausanne, Switzerland
πŸ“ Lugano, Switzerland
πŸ“ Morges, Switzerland
πŸ“ ZΓΌrich, Switzerland
πŸ“ Barnstaple, United Kingdom
πŸ“ Birmingham, United Kingdom
πŸ“ Blackpool, United Kingdom
πŸ“ Bristol, United Kingdom
πŸ“ Leeds, United Kingdom
πŸ“ Leicester, United Kingdom
πŸ“ Liverpool, United Kingdom
πŸ“ London, United Kingdom
πŸ“ Manchester, United Kingdom
πŸ“ Middlesbrough, United Kingdom
πŸ“ Newcastle Upon Tyne, United Kingdom
πŸ“ Northampton, United Kingdom
πŸ“ Nottingham, United Kingdom
πŸ“ Sheffield, United Kingdom

πŸ“‹ Eligibility Criteria

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
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

πŸ—“οΈ 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 Registration Dates

  • First Submitted 30 January 2012
  • First Submitted that Met QC Criteria 30 January 2012
  • First Posted 1 February 2012

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 June 2024
  • Last Update Posted 17 June 2024
  • Last Verified June 2024