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

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

Study Locations

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

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.

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

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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