Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Launched by MEDTRONIC · Dec 28, 2005
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called the Product Performance Report, is designed to assess how well certain heart devices made by Medtronic perform over a long period. These devices help manage heart conditions like arrhythmia (irregular heartbeat), bradycardia (slow heartbeat), heart failure, and sinus tachycardia (fast heartbeat). The study aims to understand how likely these devices are to continue working effectively after being implanted in patients.
To be part of this study, participants need to have either received a Medtronic heart device recently or be scheduled to receive one. They must also provide permission for their health information to be used in the research. Participants will be monitored over time to gather information about how their devices are functioning. It's important to note that individuals who cannot be regularly followed up or who had their device implanted at a location not included in the study will not be eligible. Overall, this trial is crucial for ensuring that heart devices are reliable and effective for patients who need them.
Gender
ALL
Eligibility criteria
- • Subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.
- Inclusion Criteria:
- • • Subject or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information as required by an institution's IRB/MEC/REB
- AND one of the following must also apply:
- • Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application
- • Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data
- Exclusion Criteria:
- • Subjects who are, or will be inaccessible for follow-up
- • Subjects with exclusion criteria required by local law (EMEA only)
- • Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
- • Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded
About Medtronic
Medtronic is a global leader in medical technology, dedicated to transforming patient care through innovative solutions and therapies. With a rich history of pioneering advancements in cardiovascular, diabetes, neurological, and orthopedic care, Medtronic is committed to improving health outcomes and enhancing the quality of life for patients worldwide. The company actively sponsors clinical trials to evaluate the safety and efficacy of its products, ensuring that rigorous scientific standards are met. Through collaboration with healthcare professionals and institutions, Medtronic seeks to drive clinical research that supports evidence-based practices and fosters advancements in medical science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Haven, Connecticut, United States
Los Angeles, California, United States
Jacksonville, Florida, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Saint Paul, Minnesota, United States
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
Pittsburgh, Pennsylvania, United States
Hong Kong, , Hong Kong
Anchorage, Alaska, United States
Denver, Colorado, United States
Kansas City, Kansas, United States
Boston, Massachusetts, United States
Albuquerque, New Mexico, United States
Manhasset, New York, United States
Rochester, New York, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Milwaukee, Wisconsin, United States
Calgary, Alberta, Canada
Montreal, Quebec, Canada
Lille, , France
Strasbourg, , France
Jerusalem, , Israel
Oslo, , Norway
Warsaw, , Poland
Barcelona, , Spain
Madrid, , Spain
Valencia, , Spain
Lund, , Sweden
Uppsala, , Sweden
Bristol, , United Kingdom
London, , United Kingdom
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Minneapolis, Minnesota, United States
Robbinsdale, Minnesota, United States
New York, New York, United States
Dallas, Texas, United States
Edegem, , Belgium
Brest, , France
Hamburg, , Germany
Heidelberg, , Germany
Ulm, , Germany
Budapest, , Hungary
Pisa, , Italy
Amsterdam, , Netherlands
Groningen, , Netherlands
Palma De Mallorca, , Spain
Birmingham, Alabama, United States
San Diego, California, United States
Torrance, California, United States
Washington, District Of Columbia, United States
Clearwater, Florida, United States
New Brunswick, New Jersey, United States
Akron, Ohio, United States
Toledo, Ohio, United States
Madison, Wisconsin, United States
Breda, , Netherlands
Rotterdam, , Netherlands
Rochester, Minnesota, United States
Little Rock, Arkansas, United States
Chula Vista, California, United States
Austin, Texas, United States
Stanford, California, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Hartford, Connecticut, United States
Louisville, Kentucky, United States
Burlington, Massachusetts, United States
Omaha, Nebraska, United States
Tyler, Texas, United States
Innsbruck, , Austria
Wien, , Austria
Leuven, , Belgium
Den Haag, , Netherlands
Enschede, , Netherlands
Lisboa, , Portugal
Porto, , Portugal
Santa Cruz De Tenerife, , Spain
Manchester, , United Kingdom
Fort Worth, Texas, United States
Baton Rouge, Louisiana, United States
Silver Spring, Maryland, United States
Allentown, Pennsylvania, United States
Brugge, , Belgium
Graz, , Austria
Linz, , Austria
Essen, , Germany
Edgewood, Kentucky, United States
Salisbury, Maryland, United States
Columbia, Missouri, United States
Leeds, , United Kingdom
Charlottesville, Virginia, United States
Bakersfield, California, United States
La Jolla, California, United States
Spokane, Washington, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Paris, , France
Aachen, , Germany
Bremen, , Germany
Dresden, , Germany
München, , Germany
Münster, , Germany
Santiago De Compostela, , Spain
Göteborg, , Sweden
Southampton, , United Kingdom
Morristown, New Jersey, United States
Praha, , Czechia
Sarasota, Florida, United States
Lansing, Michigan, United States
Brussel, , Belgium
Vandoeuvre Les Nancy, , France
Maastricht, , Netherlands
Akron, Ohio, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Plano, Texas, United States
Kingston, Ontario, Canada
Caen, , France
Rennes, , France
Marietta, Georgia, United States
Toulouse, , France
Hannover, , Germany
Seoul, , Korea, Republic Of
Liverpool, , United Kingdom
Birmingham, , United Kingdom
Düsseldorf, , Germany
Christchurch, , New Zealand
Montpellier, , France
Nantes, , France
Ashkelon, , Israel
Bologna, , Italy
Gyeonggi Do, , Korea, Republic Of
Nottingham, , United Kingdom
Yvoir, , Belgium
Palm Springs, California, United States
Lancaster, Pennsylvania, United States
Athens, , Greece
Eindhoven, , Netherlands
Blackpool, , United Kingdom
Jonesboro, Arkansas, United States
Bethesda, Maryland, United States
Ancona, , Italy
Brescia, , Italy
Basel, , Switzerland
Lausanne, , Switzerland
Milano, , Italy
Trondheim, , Norway
Bratislava, , Slovakia
Hollywood, Florida, United States
Ramat Gan, , Israel
Nieuwegein, , Netherlands
Salamanca, , Spain
Bradenton, Florida, United States
Germantown, Tennessee, United States
Bangalore, , India
Dresden, , Germany
Olympia, Washington, United States
Beijing, , China
Köln, , Germany
Safety Harbor, Florida, United States
Kuala Lumpur, , Malaysia
Douglas, , Australia
Guangzhou, , China
Hangzhou, , China
Shanghai, , China
Jena, , Germany
Villingen Schwenningen, , Germany
Girona, , Spain
Leicester, , United Kingdom
Sheffield, , United Kingdom
Danville, Pennsylvania, United States
Helsinki, , Finland
Bergen, , Norway
Calgary, , Canada
Lakewood, Colorado, United States
Avignon, , France
Gifu, , Japan
Kyoto, , Japan
Tokyo, , Japan
Evansville, Indiana, United States
Monza, , Italy
Kumamoto, , Japan
Shizuoka, , Japan
Valladolid, , Spain
Leiden, , Netherlands
Zabrze, , Poland
Bari, , Italy
Belgrade, , Serbia
Granada, , Spain
Erie, Pennsylvania, United States
Udine, , Italy
Dijon, , France
Clermont Ferrand, , France
Copenhagen, , Denmark
Taranto, , Italy
Bern, , Switzerland
Liège, , Belgium
Rancho Mirage, California, United States
Daejeon, , Korea, Republic Of
Pessac, , France
Centennial, Colorado, United States
Kagoshima, , Japan
Ljubljana, , Slovenia
Odense, , Denmark
Riyadh, , Saudi Arabia
Northampton, , United Kingdom
Geneva, , Switzerland
Poughkeepsie, New York, United States
Ypsilanti, Michigan, United States
Middlesbrough, , United Kingdom
West Des Moines, Iowa, United States
Harbin, , China
Salinas, California, United States
Marquette, Michigan, United States
Vitoria Gasteiz, , Spain
Panama City, Florida, United States
Redwood City, California, United States
Southport, , Australia
Kitakyushu, , Japan
Nagoya, , Japan
Sapporo, , Japan
Bethlehem, Pennsylvania, United States
Québec, , Canada
Ridgewood, New Jersey, United States
Suita, Osaka, Japan
New Delhi, Delhi, India
Jena, , Germany
Ocean City, New Jersey, United States
Coon Rapids, Minnesota, United States
Huntington, New York, United States
Chandler, Arizona, United States
Van Nuys, California, United States
Ventura, California, United States
Clinton, Maryland, United States
Hyattsville, Maryland, United States
Takoma Park, Maryland, United States
Saint Cloud, Minnesota, United States
Hattiesburg, Mississippi, United States
Ocean City, New Jersey, United States
Utica, New York, United States
Wilkes Barre, Pennsylvania, United States
The Woodlands, Texas, United States
Chermside, , Australia
Murdoch, , Australia
Changsha, , China
Kunming, , China
Taiyuan, , China
Tianjin, , China
Hellerup, , Denmark
Hillerød, , Denmark
århus, , Denmark
Bayonne, , France
Chambray Lès Tours, , France
La Rochelle, , France
La Tronche, , France
Neuilly Sur Seine, , France
Pringy, , France
Saint Priest En Jarez, , France
Villeurbanne, , France
Homburg, , Germany
Tübingen, , Germany
Marousi, , Greece
Reykjavik, , Iceland
Castrovillari, , Italy
Cotignola, , Italy
Lecce, , Italy
Hiroshima City, , Japan
Kawasaki, , Japan
Mitaka, , Japan
Okayama, , Japan
Shinagawa Ku, , Japan
Suita, , Japan
Toyoake, , Japan
Urasoe, , Japan
Yokohama, , Japan
ōsaka Sayama, , Japan
Hadiya, , Kuwait
Poznań, , Poland
Carnaxide, , Portugal
Creixomil, , Portugal
Santarém, , Portugal
Jeddah, , Saudi Arabia
A Coruña, , Spain
Toledo, , Spain
Skövde, , Sweden
Fribourg, , Switzerland
Lugano, , Switzerland
Zürich, , Switzerland
Niigata, , Japan
Yamagata, , Japan
Ocean, New Jersey, United States
Bad Oeynhausen, , Germany
Marlton, New Jersey, United States
Dalian, , China
Suzhou, , China
Kamakura, , Japan
Nanchang, , China
Hidaka, , Japan
Gurgaon, , India
Fuzhou, , China
Koshigaya, , Japan
Košice, , Slovakia
Shantou, , China
Suwon Si, , Korea, Republic Of
Cheongju Si, , Korea, Republic Of
Córdoba, , Spain
Be'er Sheva, , Israel
Ageo, , Japan
Thessaloníki, , Greece
Kuwait, , Kuwait
Patients applied
Trial Officials
Product Performance Report Study Leader
Study Chair
Medtronic
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials