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Trial record 1 of 3 for:    NCT01524276
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Product Surveillance Registry (PSR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01524276
Recruitment Status : Recruiting
First Posted : February 1, 2012
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic

Brief Summary:
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

Condition or disease
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

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Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medtronic Product Surveillance Registry
Study Start Date : January 2012
Estimated Primary Completion Date : January 2030
Estimated Study Completion Date : January 2030



Primary Outcome Measures :
  1. Safety and Effectiveness of Market Released products [ Time Frame: Every 6-12 months (Therapy-dependent) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects implanted with Medtronic qualifying therapy product.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524276


Contacts
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Contact: Medtronic Product Surveillance Registry rs.productsurveillanceregistry@medtronic.com

Locations
Hide Hide 362 study locations
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United States, Alabama
Recruiting
Birmingham, Alabama, United States
United States, Alaska
Recruiting
Anchorage, Alaska, United States
United States, Arizona
Recruiting
Chandler, Arizona, United States
Recruiting
Phoenix, Arizona, United States
United States, Arkansas
Recruiting
Jonesboro, Arkansas, United States
Recruiting
Little Rock, Arkansas, United States
United States, California
Recruiting
Aliso Viejo, California, United States
Recruiting
Bakersfield, California, United States
Recruiting
Chula Vista, California, United States
Active, not recruiting
Los Angeles, California, United States
Recruiting
Napa, California, United States
Recruiting
Palm Springs, 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
San Francisco, California, United States
Recruiting
Stanford, California, United States
Recruiting
Torrance, California, United States
Recruiting
Van Nuys, California, United States
United States, Colorado
Recruiting
Aurora, Colorado, United States
Recruiting
Centennial, Colorado, United States
Recruiting
Colorado Springs, Colorado, United States
Recruiting
Denver, Colorado, United States
Recruiting
Lakewood, Colorado, United States
United States, Connecticut
Recruiting
New Haven, Connecticut, United States
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States
United States, Florida
Recruiting
Bradenton, Florida, United States
Recruiting
Clearwater, Florida, United States
Recruiting
Hollywood, Florida, United States
Recruiting
Jacksonville, Florida, United States
Recruiting
Merritt Island, Florida, United States
Recruiting
Miami, Florida, United States
Not yet recruiting
Orlando, Florida, United States
Recruiting
Pensacola, Florida, United States
Recruiting
Safety Harbor, Florida, United States
Recruiting
Tampa, Florida, United States
United States, Georgia
Recruiting
Albany, Georgia, United States
Recruiting
Atlanta, Georgia, United States
Active, not recruiting
Marietta, Georgia, United States
United States, Illinois
Recruiting
Chicago, Illinois, United States
Recruiting
Maywood, Illinois, United States
Not yet recruiting
Oak Lawn, Illinois, United States
United States, Indiana
Recruiting
Evansville, Indiana, United States
Recruiting
Indianapolis, Indiana, United States
United States, Iowa
Recruiting
Iowa City, Iowa, United States
Recruiting
West Des Moines, Iowa, United States
United States, Kansas
Recruiting
Kansas City, Kansas, United States
United States, Kentucky
Recruiting
Edgewood, Kentucky, United States
Recruiting
Louisville, Kentucky, United States
United States, Louisiana
Recruiting
Baton Rouge, Louisiana, United States
Recruiting
New Orleans, Louisiana, United States
United States, Maryland
Not yet recruiting
Baltimore, Maryland, United States
Recruiting
Clinton, Maryland, United States
Recruiting
Hyattsville, Maryland, United States
Recruiting
Salisbury, Maryland, United States
Recruiting
Silver Spring, Maryland, United States
Recruiting
Takoma Park, Maryland, United States
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States
United States, Michigan
Recruiting
Ann Arbor, Michigan, United States
Not yet recruiting
Detroit, Michigan, United States
Recruiting
Lansing, Michigan, United States
Recruiting
Marquette, Michigan, United States
Recruiting
Rochester Hills, Michigan, United States
Recruiting
Royal Oak, Michigan, United States
Recruiting
Ypsilanti, Michigan, United States
United States, Minnesota
Recruiting
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
Recruiting
Saint Louis Park, Minnesota, United States
Recruiting
Saint Paul, Minnesota, United States
United States, Mississippi
Active, not recruiting
Hattiesburg, Mississippi, United States
United States, Missouri
Recruiting
Columbia, Missouri, United States
Recruiting
Kansas City, Missouri, United States
Recruiting
Saint Louis, Missouri, United States
United States, Nebraska
Recruiting
Omaha, Nebraska, United States
United States, New Jersey
Recruiting
Camden, New Jersey, United States
Recruiting
Morristown, New Jersey, United States
Recruiting
New Brunswick, New Jersey, United States
Recruiting
Ocean Township, New Jersey, United States
Recruiting
Ridgewood, New Jersey, United States
Recruiting
Teaneck, New Jersey, United States
United States, New Mexico
Recruiting
Albuquerque, New Mexico, United States
United States, New York
Recruiting
Huntington, New York, United States
Recruiting
Manhasset, New York, United States
Recruiting
New York, New York, United States
Recruiting
Poughkeepsie, New York, United States
Recruiting
Utica, New York, United States
Recruiting
Valhalla, New York, United States
United States, North Carolina
Recruiting
Durham, North Carolina, United States
Recruiting
Raleigh, North Carolina, United States
Recruiting
Winston-Salem, North Carolina, United States
United States, Ohio
Recruiting
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
Toledo, Ohio, United States
United States, Oklahoma
Recruiting
Oklahoma City, Oklahoma, United States
Recruiting
Tulsa, Oklahoma, United States
United States, Oregon
Recruiting
Portland, Oregon, United States
United States, Pennsylvania
Recruiting
Allentown, Pennsylvania, United States
Recruiting
Bethlehem, Pennsylvania, United States
Recruiting
Danville, Pennsylvania, United States
Recruiting
Erie, Pennsylvania, United States
Recruiting
Harrisburg, Pennsylvania, United States
Not yet recruiting
Hershey, Pennsylvania, United States
Recruiting
Lancaster, Pennsylvania, United States
Recruiting
Philadelphia, Pennsylvania, United States
Recruiting
Pittsburgh, Pennsylvania, United States
Recruiting
Wilkes-Barre, Pennsylvania, United States
Recruiting
Wynnewood, Pennsylvania, United States
United States, South Carolina
Recruiting
Columbia, South Carolina, United States
Recruiting
Greenville, South Carolina, United States
Recruiting
Spartanburg, South Carolina, United States
United States, South Dakota
Recruiting
Sioux Falls, South Dakota, United States
United States, Tennessee
Suspended
Germantown, Tennessee, United States
Recruiting
Nashville, Tennessee, United States
United States, Texas
Recruiting
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
United States, Utah
Recruiting
Salt Lake City, Utah, United States
United States, Vermont
Recruiting
Burlington, Vermont, United States
United States, Virginia
Recruiting
Charlottesville, Virginia, United States
Not yet recruiting
Norfolk, Virginia, United States
Not yet recruiting
Richmond, Virginia, United States
United States, Washington
Recruiting
Bremerton, Washington, United States
Recruiting
Seattle, Washington, United States
Recruiting
Spokane, Washington, United States
United States, Wisconsin
Recruiting
Madison, Wisconsin, United States
Recruiting
Milwaukee, Wisconsin, United States
Argentina
Recruiting
Buenos Aires, Argentina
Australia
Active, not recruiting
Darlinghurst, Australia
Recruiting
Southport, Australia
Austria
Active, not recruiting
Wien, Austria
Belgium
Recruiting
Brugge, Belgium
Recruiting
Brussel, Belgium
Recruiting
Charleroi, Belgium
Active, not recruiting
Edegem, Belgium
Recruiting
Genk, Belgium
Recruiting
Gent, Belgium
Recruiting
Leuven, Belgium
Recruiting
Liege, Belgium
Recruiting
Roeselare, Belgium
Recruiting
Sint-Niklaas, Belgium
Recruiting
Wilrijk, Belgium
Recruiting
Yvoir, Belgium
Brazil
Recruiting
São Paulo, Brazil
Canada, Alberta
Recruiting
Calgary, Alberta, Canada
Canada, Ontario
Recruiting
Kingston, Ontario, Canada
Recruiting
London, Ontario, Canada
Canada, Quebec
Recruiting
Montreal, Quebec, Canada
Canada
Recruiting
Quebec City, Canada
Recruiting
Quebec, Canada
Recruiting
Toronto, Canada
Chile
Recruiting
Santiago, Chile
China
Suspended
Hong Kong, China
Recruiting
Taiyuan, China
Colombia
Recruiting
Bogota, Colombia
Recruiting
Medellin, Colombia
Recruiting
Pereira, Colombia
Recruiting
Rionegro, Colombia
Czechia
Recruiting
Praha, Czechia
Denmark
Active, not recruiting
Arhus, Denmark
Recruiting
Copenhagen, Denmark
Active, not recruiting
Hellerup, Denmark
Active, not recruiting
Hillerød, Denmark
Recruiting
Odense, Denmark
Recruiting
Århus N, Denmark
Finland
Active, not recruiting
Helsinki, Finland
Recruiting
Turku, Finland
France
Recruiting
Avignon, France
Active, not recruiting
Bayonne, France
Suspended
Besançon, France
Recruiting
Bordeaux, France
Recruiting
Brest Cedex, France
Recruiting
Bron, France
Recruiting
Caen, France
Active, not recruiting
Chambray, France
Recruiting
Clermont Ferrand, France
Recruiting
Créteil, France
Recruiting
Dijon, France
Recruiting
La Rochelle, France
Active, not recruiting
La Tronche, France
Suspended
Le Kremlin-Bicêtre, France
Recruiting
Lille, France
Recruiting
Limoges, France
Recruiting
Marseille, France
Recruiting
Montpellier, France
Recruiting
Nantes, France
Active, not recruiting
Neuilly, France
Recruiting
Paris, France
Active, not recruiting
Pessac, France
Active, not recruiting
Pringy, France
Recruiting
Rennes, France
Suspended
Rouen, France
Active, not recruiting
Saint Priest, France
Recruiting
Strasbourg, France
Recruiting
Toulouse, France
Active, not recruiting
Vandœuvre-lès-Nancy, France
Active, not recruiting
Villeurbanne, France
Germany
Active, not recruiting
Aachen, Germany
Recruiting
Augsburg, Germany
Recruiting
Bad Krozingen, Germany
Active, not recruiting
Bad Oeynhausen, Germany
Active, not recruiting
Bad Rothenfelde, Germany
Active, not recruiting
Berlin, Germany
Active, not recruiting
Dresden, Germany
Active, not recruiting
Düsseldorf, Germany
Suspended
Erlangen, Germany
Recruiting
Essen, Germany
Active, not recruiting
Hamburg, Germany
Recruiting
Hannover, Germany
Recruiting
Heidelberg, Germany
Recruiting
Heilbronn, Germany
Recruiting
Homburg, Germany
Active, not recruiting
Jena, Germany
Recruiting
Karlsruhe, Germany
Recruiting
Koln, Germany
Active, not recruiting
Leipzig, Germany
Active, not recruiting
Magdeburg, Germany
Recruiting
Mannheim, Germany
Active, not recruiting
Munster, Germany
Recruiting
München, Germany
Recruiting
Regensburg, Germany
Recruiting
Stuttgart, Germany
Active, not recruiting
Tubingen, Germany
Recruiting
Ulm, Germany
Recruiting
Villingen-Schwenningen, Germany
Greece
Recruiting
Athens, Greece
Active, not recruiting
Maroúsi, Greece
Hungary
Recruiting
Budapest, Hungary
Iceland
Active, not recruiting
Reykjavik, Iceland
Israel
Recruiting
Ashkelon, Israel
Active, not recruiting
Jerusalem, Israel
Recruiting
Ramat Gan, Israel
Recruiting
Tel HaShomer, Israel
Italy
Active, not recruiting
Bari, Italy
Recruiting
Bologna, Italy
Active, not recruiting
Brescia, Italy
Recruiting
Castrovillari, Italy
Active, not recruiting
Cotignola, Italy
Suspended
Firenze, Italy
Recruiting
Lecce, Italy
Recruiting
Milano, Italy
Active, not recruiting
Palermo, Italy
Recruiting
Pavia, Italy
Active, not recruiting
Pisa, Italy
Recruiting
Udine, Italy
Japan
Recruiting
Fuchū, Japan
Recruiting
Fukuoka, Japan
Recruiting
Hirosaki, Japan
Recruiting
Hiroshima City, Japan
Recruiting
Itabashi, Japan
Recruiting
Kawasaki, Japan
Recruiting
Kitakyushu, Japan
Recruiting
Kyoto, Japan
Active, not recruiting
Mitaka, Japan
Recruiting
Nagoya, Japan
Recruiting
Okayama, Japan
Active, not recruiting
Shinagawa-Ku, Japan
Recruiting
Shinjuku-Ku, Japan
Active, not recruiting
Suita, Japan
Recruiting
Toyoake, Japan
Recruiting
Urasoe, Japan
Recruiting
Yamagata, Japan
Active, not recruiting
Yokohama, Japan
Kazakhstan
Active, not recruiting
Astana, Kazakhstan
Korea, Republic of
Recruiting
Busan, Korea, Republic of
Recruiting
Changwon, Korea, Republic of
Recruiting
Daegu, 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
Kuwait
Active, not recruiting
Hadiya, Kuwait
Malaysia
Recruiting
Kuala Lumpur, Malaysia
Mexico
Recruiting
Ciudad de mexico, Mexico
Netherlands
Active, not recruiting
Amsterdam, Netherlands
Active, not recruiting
Breda, Netherlands
Active, not recruiting
Den Haag, Netherlands
Recruiting
Eindhoven, Netherlands
Active, not recruiting
Enschede, Netherlands
Active, not recruiting
Groningen, Netherlands
Recruiting
Heerlen, Netherlands
Recruiting
Leiden, Netherlands
Recruiting
Maastricht, Netherlands
Recruiting
Nieuwegein, Netherlands
Active, not recruiting
Nijmegen, Netherlands
Recruiting
Rotterdam, Netherlands
Active, not recruiting
Utrecht, Netherlands
Norway
Active, not recruiting
Bergen, Norway
Recruiting
Lørenskog, Norway
Active, not recruiting
Oslo, Norway
Active, not recruiting
Trondheim, Norway
Poland
Active, not recruiting
Poznań, Poland
Active, not recruiting
Warszawa, Poland
Active, not recruiting
Zabrze, Poland
Portugal
Active, not recruiting
Lisboa, Portugal
Recruiting
Porto, Portugal
Puerto Rico
Recruiting
Aibonito, Puerto Rico
Recruiting
Rio Piedras, Puerto Rico
Russian Federation
Suspended
Novosibirsk, Russian Federation
Suspended
Saint Petersburg, Russian Federation
Saudi Arabia
Active, not recruiting
Jeddah, Saudi Arabia
Active, not recruiting
Riyadh, Saudi Arabia
Serbia
Recruiting
Belgrade, Serbia
Slovakia
Suspended
Bratislava, Slovakia
Recruiting
Košice, Slovakia
Slovenia
Recruiting
Ljubljana, Slovenia
South Africa
Suspended
Johannesburg, South Africa
Spain
Active, not recruiting
A Coruña, Spain
Recruiting
Badalona, Spain
Recruiting
Barakaldo, Spain
Active, not recruiting
Barcelona, Spain
Recruiting
L'Hospitalet De Llobregat, Spain
Recruiting
Madrid, Spain
Recruiting
Oviedo, Spain
Recruiting
Palma De Mallorca, Spain
Recruiting
San Sebastián, Spain
Recruiting
Santiago De Compostela, Spain
Active, not recruiting
Toledo, Spain
Recruiting
Valladolid, Spain
Active, not recruiting
Vitoria, Spain
Sweden
Recruiting
Skövde, Sweden
Active, not recruiting
Uppsala, Sweden
Switzerland
Active, not recruiting
Basel, Switzerland
Active, not recruiting
Bern, Switzerland
Active, not recruiting
Fribourg, Switzerland
Recruiting
Geneve, Switzerland
Active, not recruiting
Lausanne, Switzerland
Active, not recruiting
Lugano, Switzerland
Recruiting
Morges, Switzerland
Recruiting
Nottwil, Switzerland
Recruiting
Zürich, Switzerland
Turkey
Active, not recruiting
Ankara, Turkey
United Arab Emirates
Suspended
Abu Dhabi, United Arab Emirates
United Kingdom
Recruiting
Birmingham, United Kingdom
Active, not recruiting
Bristol, United Kingdom
Recruiting
Chelmsford, United Kingdom
Not yet recruiting
Glasgow, United Kingdom
Active, not recruiting
Leeds, United Kingdom
Active, not recruiting
Leicester, United Kingdom
Recruiting
Liverpool, United Kingdom
Recruiting
London, United Kingdom
Active, not recruiting
Manchester, United Kingdom
Recruiting
Middlesbrough, United Kingdom
Recruiting
Northampton, United Kingdom
Recruiting
Nottingham, United Kingdom
Suspended
Romford, United Kingdom
Active, not recruiting
Southampton, United Kingdom
Not yet recruiting
Stoke-on-Trent, United Kingdom
Sponsors and Collaborators
Medtronic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT01524276    
Other Study ID Numbers: PSR
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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Digestive System Diseases
Intracranial Aneurysm
Nervous System Diseases
Renal Insufficiency
Urologic Diseases
Aneurysm
Cardiovascular Diseases
Arrhythmias, Cardiac
Disease
Pathologic Processes
Vascular Diseases
Kidney Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Heart Diseases